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U.S. Food and Drug Administration
www.fda.gov
Sincerely,
Location:
Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
1 of 11
TABLE OF CONTENTS
Summary ........................................................................................................................................... 1
Administrative Data .......................................................................................................................... 1
History............................................................................................................................................... 2
Interstate (I.S.) Commerce ................................................................................................................ 3
Jurisdiction ........................................................................................................................................ 3
Individual Responsibility and Persons Interviewed .......................................................................... 4
Manufacturing ................................................................................................................................... 5
Manufacturing Codes ...................................................................................................................... 10
Complaints ...................................................................................................................................... 10
Recall Procedures............................................................................................................................ 10
General Discussion with Management ........................................................................................... 10
Exhibits Collected ........................................................................................................................... 10
Attachments .................................................................................................................................... 11
SUMMARY
A limited inspection of this registered human tissue establishment was performed as part of the
Division of Biological Products Operations 1 FY’18 Work Plan under eNSpect Operation ID #41755.
This assignment was issued to gather information regarding the firm’s current operations.
The firm has no previous FDA inspection history.
The current inspection disclosed that the firm processes, packages, stores, labels, and distributes human
amniotic fluid for the treatment of osteoarthritis. The firm also processes, packages, stores, labels, and
distributes human placental- derived mesenchymal stem cells for the treatment of skin damage.
No FDA-483, Inspectional Observations, was issued to the firm. On 10/24/2017, a close-out discussion
was held with Dr. Duncan Ross, Ph.D.
No samples were collected and no refusals were encountered.
ADMINISTRATIVE DATA
Inspected firm: Kimera Society, Inc.
Location: 2831 Corporate Way
Miramar, FL 33025
Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
Phone: 305-454-7836
FAX: 1-866-707-2673
Mailing address: 1521 Alton Rd # 580
Miami Beach, FL 33139-3301
Dates of inspection: 10/19/2017, 10/24/2017
Days in the facility: 2
Participants: Shavon L Square, Investigator
On 10/19/2017, I presented my credentials and issued FDA-482, Notice of Inspection, to Dr. Duncan
Ross, Ph.D. (Attachment 1). Dr. Ross is the Chief Executive Officer (CEO), and the most
responsible person at the firm. On 10/24/2017, I returned to the firm to collect additional information
on the XoGlo™ product. A second FDA-482, Notice of Inspection, was issued to Dr. Duncan Ross,
Ph.D., CEO (Attachment 2).
HISTORY
Kimera Society, Inc. is a non-profit corporation that was incorporated in the state of Florida on
11/30/2012. Dr. Duncan Ross, Ph.D. is the CEO and the highest ranking official at the firm. Kimera
Society, Inc. currently operates out of two locations: [redacted] 2831 Corporate Way Miramar,
FL 33025. Kimera Society located at 2831 Corporate Way Miramar, FL 33025 is currently
registered with the FDA (Attachment #3).
[Redacted]
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Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
According to Dr. Ross, Kimera Society, Inc. is currently staffed with employees: [Redacted] The
firm’s business hours are 8:00 AM to 5:00 PM, Monday through Friday. According to Dr. Ross,
Kimera Labs, Inc. is currently staffed with employees: Dr. Ross, [Redacted]. The firm’s business
hours are 8:00 AM to 5:00 PM, Monday through Friday. Dr. Douglas Spiel, MD, is the Medical
Director for both firms.
FDA correspondence and FMD-145 should be addressed to the following individual:
Dr. Duncan Ross, Ph.D., CEO
1521 Alton Road #580
Miami Beach, FL 33139
INTERSTATE (I.S.) COMMERCE
The firm receives amniotic fluid from [Redacted] and [Redacted]. According to Dr. Ross, the
amniotic fluid is used to manufacture the Amnio2 and Celapure products. Dr. Ross stated that the
human placental-derived mesenchymal stem cells are used to manufacture the XoGlo™ product.
Dr. Ross stated that 100% of the amniotic fluid products are distributed in interstate commerce. The
firm distributes Amnio2 to [Redacted]. Dr. Ross stated that XoGlo™ is also distributed to the
aforementioned customers in addition to several doctors throughout the United States. Dr. Ross
explained that 50% of the XoGlo™ products are distributed in intrastate commerce and 50% are
distributed in interstate commerce.
The firm does not currently import or export products.
The firm’s products are promoted at conferences and on the company’s website:
www.kimeralabs.com. Exhibit 1 includes a copy of the promotional pamphlet that is used to market
the Amnio and Amnio2 products. Exhibit 2 includes a copy of the promotional pamphlet that is
used to market the XoGlo™ product.
JURISDICTION
The firm currently processes, packages, stores, labels, and distributes human amniotic fluid products
under the Amnio2 and Celapure brand names for the treatment of osteoarthritis. The firm also
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Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
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processes, packages, stores, labels, and distributes human placental-derived mesenchymal stem cells
under the XoGlo™ brand name for the treatment of skin damage:
Amnio2 is a human amniotic fluid derived product with no cells or Dimethyl Sulfoxide
(DMSO). The product is packaged into 0.5cc, 1.0cc, and 2.0cc cryovials. According to Dr.
Ross, this product is marketed for the treatment of osteoarthritis and is injected directly into
the knee. A copy of the Amnio2 product label is included in this report as Exhibit 3.
Amnio is a human amniotic fluid derived product that is cryo-preserved with Dimethyl
Sulfoxide (DMSO) and contains live cells. Dr. Ross stated that he no longer manufactures
this product; however, the firm continues to market this product in their promotional material.
Refer to Exhibit 1 for a copy of the promotional material for Amnio.
Celapure is a human amniotic fluid derived product with no cells or Dimethyl Sulfoxide
(DMSO). This product is privately labeled for Catalyst Sales & Marketing, LLC located in
Houston, TX (FEI: 3011895746). Dr. Ross stated that Celapure and Amnio2 are the same
products. However, Celapure is packaged into 0.5cc, 1.0cc, and 2.0cc syringes, while Amnio2
is packaged into 0.5cc, 1.0cc, and 2.0cc cryovials. According to Dr. Ross, this product is
marketed for the treatment of osteoarthritis and is injected directly into the knee. A copy of
the Celapure product label is included in this report as Exhibit 4.
XoGlo™ is a human placental-derived mesenchymal stem cell product that is processed with
[Redacted] and saline. The product is packaged into 5ml cryovials. According to Dr. Ross,
this product is marketed for the treatment of skin damage and is applied directly to the skin
(i.e. topical). Refer to Exhibit 10, Page 10 for an example of the XoGlo™ product label and
Exhibit 2 for a copy of the promotional material.
INDIVIDUAL RESPONSIBILITY AND PERSONS INTERVIEWED
Dr. Duncan Ross, Ph.D., CEO
Dr. Ross is the CEO and Founder of Kimera Society Inc. and Kimera Labs, Inc. Dr. Ross has the
power, duty, and responsibility to prevent, detect, and correct violations. Dr. Ross’ responsibilities
include, but are not limited to: overseeing all protocol development, writing Standard Operating
Procedures (SOPs), processing, and sales. Dr. Ross was present throughout the inspection.
Dr. Douglas Spiel, MD, Medical Director
Dr. Ross stated that Dr. Spiel is responsible for reviewing all donor records. Dr. Spiel was not
present during the inspection.
Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
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[Redacted] Quality Director at Kimera Labs
[Redacted] responsibilities include, but are not limited to: reviewing SOPs, qualifying vendors,
Quality Control, and purchasing. [Redacted] reports to Dr. Ross. Ms. [Redacted] was present on
10/19/2017.
[Redacted] Laboratory Technician
[Redacted] responsibilities include, but are not limited to: processing, packaging, shipping, and
labeling. [Redacted] reports to Dr. Ross. Ms. [Redacted] was present on 10/19/2017.
MANUFACTURING
The firm processes, packages, stores, labels, and distributes human amniotic fluid products for the
treatment of osteoarthritis (i.e. Amnio2 and Celapure). The firm also processes, packages, stores,
labels, and distributes human placental-derived mesenchymal stem cells for the treatment of skin damage
(i.e. XoGlo™).
Human Amniotic Fluid (i.e. Amnio2 and Celapure)
The amniotic fluid is collected from volunteer donors who have undergone a planned caesarean
section. Dr. Ross explained that for each donor, he receives the donor’s informed consent, physical
exam, medical social history questionnaire, and communicable disease test results (Exhibit 5).
According to Dr. Ross, donor-eligibility determination is determined by [Redacted]
Dr. Ross and Ms. [Redacted] explained the Amnio2 and Celapure manufacturing process as
follows:
1. The amniotic fluid is initially inspected for acceptability and acclimatized using a water bath.
2. The storage container is liberally sprayed with 70% IPS (70% IPA/ 30% water for injection),
dried with a lint-free towel, and weighed.
3. The amniotic fluid is transferred to the processing hood and individually pipetted into 50 ml
conical tubes.
4. Each vial is centrifuged at 300g for 10 minutes to pellet cells and extracellular matrix.
5. The extracellular matrix is filtered through the following filters: [Redacted]
Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
6. The product is packaged according to the customer’s specifications and stored at -80°C until
final distribution.
Dr. Ross stated that the amniotic fluid is processed in an ISO 5 Laminar Flow Glovebox/ Isolator
(LFGI) which is inside an ISO 7 clean room. The LFGI is manufactured by Germfree in Ormond
Beach, FL. According to Dr. Ross, approximately 200 units of amniotic fluid are manufactured per
donor.
Dr. Ross provided the following statistics showing the number of donors and the amount of distributed
products from each lot:
Donor #
(lot #)
Product Date Manufactured No. Products Distributed
AM16H003
(lot 001)
Human Placenta 08/03/2016 Research and Development
Use only
TGAM17D006
(lot 002)
Amniotic Fluid 04/06/2017 158 units
TGHC17D038
(lot 003)
Amniotic Fluid 04/27/2017 71 units
TGMC17F002
(lot 004)
Amniotic Fluid 06/15/2017 0 units
TGSV17F023
(lot 005)
Amniotic Fluid 06/21/2017 0 units
E217H002RBI
(lot 006)
Amniotic Fluid 08/04/2017 85 units
Tracking
The firm currently has a system in place to track amniotic fluid products from the donor to the
recipient and vice versa. Dr. Ross stated that each product is distributed with an “Amniotic Fluid
Traceability Record” and five extra product labels. He also stated that each product is tracked by a
unique serial number which is assigned by the collection facility. A copy of the “Amniotic Fluid
Traceability Record” is included in this report as Exhibit 6.
Human Placental- Derived Mesenchymal Stem Cells (MSC) (i.e. XoGlo™)
The firm uses human placental-derived mesenchymal stem cells to manufacture XoGlo™, a topical
product used to treat skin damage (Exhibit 2). [Redacted] On 10/19/2017, Dr. Ross stated that
XoGlo™ is a cosmetic product. However, the instructions for use for the product specifically
include tissue recovery (i.e. donor eligibility statement) and donor screening information. The
XoGlo™ instructions for use are included in this report as Exhibit 7.
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Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
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According to Dr. Ross, the firm does not receive donor-eligibility documents for the stem cell
products. He stated that the Certificate of Analysis (CoA) is the only document that is shipped with
the product. He also stated that all stem cells are tested for communicable diseases and referred me
to a “Quality Control” statement in the COA which states “Each lot of primary cells is tested found
non-reactive to HIV-1, HIV-2, HTLV 1, HTLV II, Hepatitis B, Hepatitis C, Syphilis and CMV.
However, no known test can offer complete assurance that the viruses that these infectious diseases
are not present. Since we cannot test all pathogens, please treat the culture as a potential infectious
reagent at Biosafety Level 2 or higher.” Refer to Exhibit 8 for a copy of the CoA.
The XoGlo™ manufacturing process is as follows:
[Redacted]
A copy of the XoGlo™ Master Production Schema was provided by Dr. Ross and is included in this
report as Exhibit 9. Copies of the “XoGlo™ Master Formula Record”, the “Production flowchart”,
and the “Production Overview” are also included in this report as Exhibit 10. According to Dr.
Ross, the following components are used to manufacture the product:
1. [Redacted]
2. [Redacted]
Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
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3. [Redacted]
4. [Redacted]
5. [Redacted]
6. Baxter 0.9% Sodium Chloride USP
Dr. Ross provided the following statistics showing the number of XoGlo™ products that have been
distributed by the firm since 09/2016:
Lot No. Date Amount
Total Products Sold
A list of the firm’s current inventory is included in this report as Exhibit 16.
Dr. Ross stated that each unit of XoGlo™ is packaged into a 5ml vial. The product is stored at -80°C
until final distribution. The firm does not track this product from donor to consignee and vice versa.
[REDACTED]
Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
Testing
Communicable Disease
Dr. Ross stated that LABS, Inc. located at 6933 S. Revere Parkway, Centennial, CO 80112 (FEI:
1000477683) performs communicable disease testing for amniotic fluid donors. LABS, Inc. is an
FDA registered facility. Donors are tested for Hepatitis B Core total antibody, Hepatitis B Surface
Antigen, Hepatitis C antibody, HIV-1/ HIV-2 plus O, HTLV I/II antibody, syphilis, WNV NAT, and
HIV, HCV, and HBV NAT testing.
Sterility and Endotoxin Testing
Dr. Ross stated that LABS, Inc. performs sterility and endotoxin testing for the Amnio2, Celapure,
and XoGlo products. Two samples from each lot of amniotic fluid and 1 out of every 30 vials of
XoGlo™ are sent to LABS, Inc. for testing.
Environmental Monitoring
Dr. Ross stated that 6 RODAC® plates are placed throughout the processing area (clean room and
the LFGI) and are sent to LABS, Inc. once a month for testing.
Product Returns
The firm does not have a return procedure and reported no returns.
[Redacted]
HCT/P Deviations
There were no HCT/P deviations reported by the firm.
Future Production Overview
The firm intends on processing human placentas in the future as explained by the “Future Production
Overview” document. A copy of this document is included in this report as Exhibit 19.
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Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
MANUFACTURING CODES
Dr. Ross stated that all products are labeled with an alpha-numeric code as shown in the following
example:
AF20201
AF2- Product name (i.e. amnion2)
02- Product size (i.e. 2cc)
01- All amniotic products end in 01
All amniotic fluid products are also labeled with a serial number (SN) which is assigned by the
collection facility. The SN is used by the firm to track products from the donor to the recipient and
vice versa.
COMPLAINTS
Dr. Ross reported no complaints. The firm does not currently have complaint procedures or a
compliant file.
RECALL PROCEDURES
Dr. Ross reported no recalls. The firm does not currently have recall procedures.
GENERAL DISCUSSION WITH MANAGEMENT
On 05/24/2017, a close-out discussion was held with Dr. Duncan Ross, Ph.D., CEO. No FDA-483,
Inspectional Observation, was issued to the firm.
EXHIBITS COLLECTED
1 2 3 4 5 6 7 8 9 10 11 12
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Establishment Inspection Report FEI: 3011069063
Kimera Society, Inc. EI Start: 10/19/2017
Miramar, FL 33025 EI End: 10/24/2017
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13 GlutaMAX ™ - l (100X) 200mM Certificate of Analysis, 1 page 14 AF Attachment Factor 1X Certificate of Analysis, 1 page
15 TrypLE (TM) Select CTS (TM) Certificate of Analysis, 2 pages
16 XoGlo™ Inventory, 6 pages
17 Packaging Amniotic Fluid Standard Operating Procedure, 2 pages
18 Shipment of Amniotic Fluid Standard Operating Procedure, 8 pages
19 Future Production Overview Document, 1 page
ATTACHMENTS
1 FDA-482, Notice of Inspection, 3 pages 2 FDA-482, Notice of Inspection, 3 pages
3 Kimera Society 2017 HCT/P Registration, 2 pages
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