ANSI-ASQ National Accreditation Board - Nelson Labs National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, ... USP STP0152 based on AAMI TIR 12, USP,

CERTIFICATE OF ACCREDITATION

ANSI-ASQ National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, VA 22314, 877-344-3044

This is to certify that

Nelson Laboratories, Inc. 6280 S. Redwood Road

Salt Lake City, UT 84123

has been assessed by ANAB

and meets the requirements of international standard

ISO/IEC 17025:2005

while demonstrating technical competence in the field(s) of

TESTING

Refer to the accompanying Scope(s) of Accreditation for information regarding the

types of tests to which this accreditation applies.

AT-1382

Certificate Number

ANAB Approval

Certificate Valid To: 03/16/2017

Version No. 002 Issued: 03/09/2016

This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005.

This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory

quality management system (refer to joint ISO-ILAC-IAF Communiqué dated January 2009).

Version 002 Issued: 03/09/2016 Page 1 of 4

500 Montgomery St. Suite 625│ Alexandria, VA 22314│703-836-0025 │ www.anab.org

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005

Nelson Laboratories, Inc. 6280 S. Redwood Road, Salt Lake City, UT 84123

Kevin Buckingham Phone: 801-290-7500

[email protected] www.nelsonlabs.com

TESTING

Valid to: March 16, 2017 Certificate Number: AT - 1382

I. Microbiological

ITEMS, MATERIALS

OR PRODUCTS

TESTED

SPECIFIC TESTS OR

PROPERTIES

MEASURED

SPECIFICATION,

STANDARD METHOD OR

TECHNIQUE USED

*KEY EQUIPMENT OR

TECHNOLOGY

Medical Devices,

Raw Materials Agar Overlay

STP0031 based on

ANSI/AAMI/ISO 10993-1,5,12

USP <87>, USP<1031>

ISO Class 5 Hoods

Microscope

Incubators

Antimicrobial

Preservatives

Antimicrobial Preservative

Effectiveness

STP0131 based on USP <51>,

STP0132 based on

USP <51> and EP 5.1.3

Incubators

Medical Devices,

Drugs Bacterial Endotoxins

STP0046 based on USP <85>,

USP<161>, USP<797>,

AAMI ST72, EP 2.6.14,

ASTM D7102-04, BS EN 455-3

Microplate Reader

Medical & Surgical Face

Masks

Bacterial Filtration

Efficiency (BFE)

Viral Filtration Efficiency

(VFE)

STP00004 and STP0007 based on

ASTM F2101, EN14683, ASTM

F2100

Andersen Sampler

Textiles,

Gloves

Barrier Testing (Viral

Penetration)


ASTM F1671,

AAMI PB70, ISO16604

ISO Class 5 Hoods

Incubators

Textiles,

Medical Devices,

Tissues,

Pharmaceuticals

Bioburden

STP0036 based on ISO 11737-1,

STP0050 based on

ISO11737-2, 11137-01 and -02,

AAMI TIR 17, 35, 37,

STP0051 based on ISO 11737-01

and -02, 11137-01 and -02, AAMI

TIR 17, 33, 37 and STP0044 based

on

ISO11137-01 and -02,

AAMI TIR 33, 35

ISO Class 5 Hoods

Incubators



ITEMS, MATERIALS

OR PRODUCTS

TESTED

SPECIFIC TESTS OR

PROPERTIES

MEASURED

SPECIFICATION,

STANDARD METHOD OR

TECHNIQUE USED

*KEY EQUIPMENT OR

TECHNOLOGY

BIs, PCDs

Biological Indicators

(Population verification,

Process Challenge Device

(PCD) Preparation, BI

Sterility)

STP0045,

STP0079, and SOP0180 based on

USP<55>, ISO 11138-1 to -4, ISO

11135-1 to -2, ISO 14161, ISO

14937,

ISO 17665-2, AAMI TIR 13, 14,

16, BS EN 550

BI Sterility Suite

Class 5 Hoods

Incubator

Medical Devices, Reusable

Devices

Cleaning, Disinfection,

Sterilization

STP0083and STP0129 based on

AAMI TIR 12, 30, ASTM E1837,

ISO17664

STP0086 based on ANSI/AAMI

ST79, AAMI TIR12,

ANSI/AAMI/ISO 17665, USP

<1211>

STP0152 based on AAMI TIR 12,

USP<1211>, ANSI/AAMI/ ISO

11135-1

STP0153 based on

ANSI/AAMI/ISO 14937, AAMI

TIR12, USP <1211>

STP0159 based on ISO 17664,

ANSI/AAMI ST79, ANSI/AAMI

ST77, ANSI/AAMI/ISO 11135,

AAMI TIR30

Washer/Disinfectors

Sterilizers (Steam, EO, VHP)

Packaging Materials for

Medical Device &

Pharmaceutical

Container Closure (Bacterial

Ingress)

STP0164 based on PDA TR 27

and FDA Guidance for Industry:

Container and Closure Integrity

Testing

Pressure/Vacuum Vessel

Incubators

Medical Devices,

Raw Materials Hemolysis

STP0033 based on

ANSI/AAMI/ ISO 10993-1,4,12

STP0155 based on ASTM F756-

08, STP0093 based on

ANSI/AAMI/ISO 10993-1,4,12

and ASTM F756-08

Spectrophotometer

Incubators

Medical Devices,

Raw Materials MEM Elution

STP0032 based on

ANSI/AAMI/ ISO 10993-1,5,12

USP <87>, USP<1031>

ISO Class 5 Hoods

Microscope

Incubators

Filters

Microbial Retention

(Including Filter Bubble

Point/Integrity Test)

STP0103 based on

ASTM F838-05

Flow Meter

Pressure Gauge

ISO Class 5 Hood

Incubators

Medical Devices,

Pharmaceuticals

Microbiological Examination

of NonSterile Products

(Enumeration and Specified

Organisms, USP 61/62)


USP<61> and USP<62>

ISO Class 5 Hoods

Incubators



ITEMS, MATERIALS

OR PRODUCTS

TESTED

SPECIFIC TESTS OR

PROPERTIES

MEASURED

SPECIFICATION,

STANDARD METHOD OR

TECHNIQUE USED

*KEY EQUIPMENT OR

TECHNOLOGY

Medical Devices,

Pharmaceuticals

Organism Identification

(Genetic and Gram Stain)

STP0105, STP0173 and STP0037

based on USP<1113>

Genetic Sequencers

Thermocyclers

Automatic Gram Stainer

ISO Class 5 Hoods

Incubators

Microscopes

Medical Devices,

Pharmaceuticals,

Biologics,

Tissues

Product Sterility

Bacteriostasis / Fungistasis


USP<71>, USP<161>,

USP<797>, ISO 11737-2,

1137-01 and -02, PIC/S PI 012-3,

EP 2.6.1, JP XV 4.06, ISO 17665,

AAMI TIR 33

ISO Class 5 Cleanrooms and

Hoods

Incubators

Water, Food, Cosmetics,

Pharmaceuticals Standard Plate Counts

STP-0035 based on USP <71>

STP0169 based on USP<61>

ISO Class 5 Hoods

Incubators

Textiles,

Gloves

Barrier Testing:

Synthetic Blood and Water

Resistance (Hydrostatic

Pressure, Impact Penetration)

STP0061, STP0071 and STP0072

based on ASTM F1670,

AAMI PB70, ISO 16603,

AATCC 42 and 127

Hydrostatic Head Tester

Incubators

Packaging Materials for

Medical Device &

Pharmaceutical

Container Closure (Dye

Ingress)

STP0149 based on

ANSI/AAMI/ISO 11607-1,2,

ASTM D4491-07, PDA TR 27and

FDA Guidance for Industry:

Container and Closure Integrity

Testing

Vacuum Vessel

UV/Vis Spectrophotometer

Medical Devices Ethylene Oxide (EO)

Residual Analysis

STP0016 based on

ANSI/AMMI/ISO10993-7, 2008,

USP <621>

Gas Chromatograph (GC)

Medical Devices, Injectables

and Ophthalmic Solutions,

Pharmaceutical Products

Particulates

STP0011 based on

USP <788>, <789>, EP 2.9.19,

2.9.31, BP Appendix XIII A,

BH EN 45502-1, 45502-2-1

ISO 8536-4

Liquid Particle Counting

System

Microscope system

Medical & Surgical Face

Masks

Particulate Filtration

Efficiency (PFE) STP0005 based on ASTM F2299

Particle Generator

Particle Counter

Water – USP,

Water – EP

Water Purity Analysis

TOC

Conductivity

pH

STP-0024 based on USP<1231>,

USP<1230> and

all USP monograph waters,




Ion Analyzer

TOC Analyzer



ITEMS, MATERIALS

OR PRODUCTS

TESTED

SPECIFIC TESTS OR

PROPERTIES

MEASURED

SPECIFICATION,

STANDARD METHOD OR

TECHNIQUE USED

*KEY EQUIPMENT OR

TECHNOLOGY

Polymers, Non-volatile

Residue, Materials

FTIR,

Material Characterization

STP0021 based on

USP <851> and USP <197> FTIR Spectrophotometer

Notes: 1. * = As Applicable

2. This scope is formatted as part of a single document including the Certificate of Accreditation No. AT-1382

_________________________ Vice President

600 N. Plankinton Ave., Suite 300 Milwaukee, WI 53203 USA

414-347-9858

500 Montgomery St., Suite 625 Alexandria, VA 22314 USA

703-836-0025 www.anab.org

5300 W Cypress Street, Suite 180 Tampa, FL 33607 USA

813-443-0517

February 10, 2015 VIA EMAIL Kevin Buckingham Nelson Laboratories, Inc. 6280 S. Redwood road Salt Lake City, UT 84123 RE: New Name, Look, and Changes for the ANSI-ASQ National Accreditation Board Dear Kevin: In keeping with our announcement last November 13, the ANSI-ASQ National Accreditation Board has moved to the single ANAB brand. The Calibration and Testing laboratories program, formerly called ACLASS, will now be known as ANAB. ANAB now encompasses all of our accreditation programs, including management systems CBs, calibration and testing laboratories, forensic testing laboratories, medical testing laboratories, medical examiners, inspection bodies, forensic inspection agencies and police crime units, proficiency test providers, and reference material producers. Effective immediately, all documents and forms for the company supporting all our conformity assessments programs are updated with the new logo. We want all our customers, assessors, friends, and interested parties to be assured that this brand consolidation is a focusing improvement and will be rolled out over the coming two to three years. As each initial or surveillance or re-assessment is done over the coming year in our laboratory- and forensics-related programs, we will update the scopes of accreditation and certificates to include the new logo. After posting these to our website as updates, we will send the related accreditation symbol files to each organization for their use. Our customers have two years to make the changes internally, to our updated name and symbol. Also please note that we are no longer listing separate links to the accreditation certificate and the scope of accreditation on our website. Both items are now uniformly posted on our website as a single document and pdf file and link. The first page will represent the certificate sheet, and all additional pages will represent the scope of accreditation. Please feel free to contact your laboratory- or forensics-related ANAB Accreditation Manager for more information. Sincerely, Kelly Feist Kelly Feist Accreditation Manager, Testing

Virgil M. McCarthy

Subject: RE: Registration Number 1721109: Successful 2016 Medical Device Establishment

Registration

From: CDRH Registration and Listing [mailto:[email protected]]

Sent: Saturday, November 21, 2015 6:21 PM To: Matthew D. Cushing

Subject: Registration Number 1721109: Successful 2016 Medical Device Establishment Registration

Dear Matthew Cushing:

This e-mail provides confirmation that the annual registration for the following medical device establishment has been successfully completed for 2016:

Registration Number: 1721109 Owner Operator Number: 10042149 NELSON LABORATORIES, INC. 6280 S Redwood Rd Salt Lake City, UT 84123 UNITED STATES

If you do not see a registration number assigned to the establishment and your establishment previously had one, please send an email to [email protected] and include the registration number you believe is assigned to your establishment. We will review and determine if a duplicate registration has been created for your establishment.

Your registration is valid until December 31, 2016. Registration for 2017 will be conducted between October 1 and December 31, 2016.

Please note that registering your device facility and listing your devices does not, in any way, constitute FDA approval of your facility or your devices.

Should you have any questions, please send an e-mail to the CDRH Registration and Listing Helpdesk at [email protected].

See Instructions for OMB Statement. FORM APPROVED:OMB No.0910-0543. Expiration Date: 3/31/2017

FORM FDA - 3356 (5/14)

DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

6280 South Redwood Road

Nelson Laboratories, Inc

801-290-7500 EXTa. PHONE

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code)

a. PHONE EXT801-290-7692

PART I - ESTABLISHMENT INFORMATION PART II - PRODUCT INFORMATION

4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code)

Salt Lake City, Utah 84123

9. REPORTING OFFICIAL'S SIGNATURE

c. TITLE Regulatory Affairs Manager

a. TYPED NAME

d. DATE

Matthew D. Cushing, BS

5. ENTER CORRECTIONS TO ITEM 4

7. ENTER CORRECTIONS TO ITEM 6

VALIDATION--FOR FDA USE ONLY

3. OTHER FDA REGISTRATIONS

a. BLOOD FDA 2830

b. DEVICES FDA 2891

c. DRUG FDA 2656

NO.

NO.

NO.

FEI: 0001721109

FEI: 0151663234

10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps

Xa. Bone

b. Cartilage

c. Cornea

d. Dura Mater

VALIDATED BY FDA:20-NOV-2015DISTRICT: DenverPRINTED BY FDA:03-DEC-2015ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES,

AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)(See reverse side for instructions)

8. U.S. AGENT

b. E-MAIL [email protected]

a. E-MAIL

b. PHONE

3000233845FEI:

1. REGISTRATION NUMBER 2. REASON FOR SUBMISSIONa. INITIAL REGISTRATION / LISTING

c. CHANGE IN INFORMATION

b. ANNUAL REGISTRATION / LISTINGX

19-NOV-2015

s.

t.

u.

v.

1

(FDA Establishment Identifier)

d. INACTIVE

Nelson Laboratories, IncAttn: Matthew D. Cushing, BS6280 South Redwood RoadSalt Lake City, Utah 84123

b. SATELLITE RECOVERY ESTABLISHMENT

c. TESTING FOR MICRO-ORGANISMS ONLY

Establishment Functions

Types of HCT / Ps

f. Fascia

g. Heart Valve

h. Ligament

e. EmbryoSIPDirectedAnonymous

X

X

X

X

X

X

X

X

X

X

X

X

X

X

i. OocyteSIPDirectedAnonymous

j. Pericardium

l. Sclera

n. Skin

p. Tendon

r. Vascular Graft X

X

X

X

X

X

X

X

X

X

X

11. HC

T/P

s D

ES

CR

IBE

D IN

21 C

FR

1271.10

12. HC

T/P

s R

EG

UL

AT

ED

AS

M

ED

ICA

L D

EV

ICE

S

13. HC

T/P

s R

EG

UL

AT

ED

AS

D

RU

GS

OR

B

IOL

OG

ICA

L D

RU

GS

Recover Screen Test Package Process Store Label Distribute

14. PROPRIETARY NAME(S)

q. Umbilical Cord Blood

AutologousFamily RelatedAllogeneic

o. Somatic Cell Therapy Products

XXX


X X

m. SemenSIPDirectedAnonymous

k. Peripheral Blood Stem

XXX


X X

X(MANUFACTURING ESTABLISHMENT FEI NO._________________

Certificate of GMP Compliance of a Manufacti. Irer

Australian Government

Department of HealthTherapeutic Goods Administration

Certificate Number:

M1-2013-CE-08/22-I

Issued to:

Nelson Laboratories Inc

Manufacturing Site Address:

6280 South Redwood Road

Salt Lake City UT United States Of America

The Therapeutic Goods Administration, the Competent Authority of Australia, confirms that thismanufacturer has been inspected following section 32EA(I) of the Theropeutic GoodsAct1989inconnection with manufacturers of Biologicals (items made from or containing human cells orhuman tissues) located outside Australia.

From the knowledge gained during inspection of this manufacturer, the latest of, that wasconducted on 20 to 23 Ianuary 2015, it is considered that the manufacturer complies with theGood Manufacturing Practice (GMP) requirements of the Australian Code of Good ManufacturingPractice for Human Blood and Tissues (2000).

This certificate reflects the status of the manufacturing site at the time of the inspection notedabove. This certificate remains valid until the expiry date provided that re-inspections areconducted as determined by the Therapeutic Goods Administration as the issuing Authority.This certificate should not be relied upon to reflect the compliance status after the expiry date.

EXPIRY DATE : 23 Ianuary 201.8

ISSUE DATE : 7 September 201.5

Name and signature of an authorised person of the Competent Authority of Australia:

Signed:

This centncate Is valid only If the securlty provisions Iblue and grey curved dotted lines on the bottom half oreach pagej are vlsible

This certificate remains valld only if re-Inspections are conducted when scheduled by rhe Therapeutic Goods Administration

The authenticity of this certificate may be verified with the Therapeutic Goods Administration as the Issuing authority

PO Box 100 Waden ACT 2606 ABN 409394068040262328444 0262328605 info@Iga. gov. au WWW tga gov au

...........^:^,*....^:^:.........Hongxiajin

Director, Licencing and CertificationManufacturing Quality Branch

Page I of 2

Certificate of GMP Compliance of a Manufacti. Irer

*

* *

Allstralian Government

Department of HealthTherapeutic Goods Administration

MANUFACTURING OPERATIONS

This certificate covers the following steps in the manufacture of therapeutic goods at themanufacturing site address specified above.

Manufacturing Type

Human Tissue

The following limitations are applicable to these manufacturing operations:

The certificate is restricted to sterility testing, including barteriostasis andfungistasis testing.

Certificate Number:

M1-2013-CE-08/22-I

Sterility

Sterile & Non Sterile

Manufacturing Step

Testing microbial

Name and signature of an authorised person of the Competent Authority of Australia:

Signed:

This certificate Is valid only Irthe security provisions Iblue and grey curved dotted lines on the bottom half of each pagej are visible.

This certificate remains valid only it re. irisp CLIons are conducted when scheduled by the Therapeutic Goods Administration.

The authentl IQ, orthls centncare may be verified with the Therapeutic Goods Administration as the Issuing authority

PO Box 100 Waden ACT 2606 ABN 40 9394068040262328444 0262328605 ' : info@19a. gov. au WWW tga gov au

...,................,....................................

Hongxia jinDirector, Licencing and Certification

Manufacturing Quality Branch

I^,- ^-,-

TGA'^:;^^^;:^,Page 2 of 2

Documents

ANSI-ASQ National Accreditation Board - Nelson Labs National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, ... USP STP0152 based on AAMI TIR 12, USP,