Certifications: Table of Contents. Document # Title Page(s)

Size: px

Start display at page:

Download "Certifications: Table of Contents. Document # Title Page(s)"

Gary Gervais Parker
6 years ago
Views:

Certifications: Table of Contents Document # Title Page(s) 1 ISO 17025: Certificate of Accreditation 2 2 ISO 17025: Scope of Accreditation 3-6 3 FDA: Medical Device Establishment 7 Registration 4

1 Certifications: Table of Contents Document # Title Page(s) 1 ISO 17025: Certificate of Accreditation 2 2 ISO 17025: Scope of Accreditation FDA: Medical Device Establishment 7 Registration 4 FDA: Generic Drug Statement of 8 Compliance 5 FDA: Drug Establishments Registration 9 6 FDA: Establishment Registration and 10 Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7 EU/EMA: European Certificate of GMP Compliance 8 TGA: Certificate of GMP Compliance US: DEA Registration Utah: State Business License S. Redwood Road, Salt Lake City, UT, nelsonlabs.com

CERTIFICATE OF ACCREDITATION ANSI-ASQ National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, VA 22314, 877-344-3044 This is to certify

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

accreditation applies. AT-1382 Certificate Number Certificate Valid: 03/14/2017-03/16/2019 Version No.

2 CERTIFICATE OF ACCREDITATION ANSI-ASQ National Accreditation Board 500 Montgomery Street, Suite 625, Alexandria, VA 22314, This is to certify that Nelson Laboratories, LLC 6280 S. Redwood Road Salt Lake City UT has been assessed by ANAB and meets the requirements of international standard ISO/IEC 17025:2005 while demonstrating technical competence in the field of TESTING Refer to the accompanying Scope of Accreditation for information regarding the types of tests to which this accreditation applies. AT-1382 Certificate Number Certificate Valid: 03/14/ /16/2019 Version No. 003 Issued: 03/14/2017 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).

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Nelson Laboratories, LLC 6280 S. Redwood Road, Salt Lake City, UT 84123 Kevin Buckingham Phone: 801-290-7500 KBuckingham@nelsonlabs.

3 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Nelson Laboratories, LLC 6280 S. Redwood Road, Salt Lake City, UT Kevin Buckingham Phone: TESTING Valid to: March 16, 2019 Certificate Number: AT 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 ,5,12 USP <87>, USP<1031> ISO Class 5 Hoods Microscope Antimicrobial Preservatives Antimicrobial Preservative Effectiveness STP0131 based on USP <51>, STP0132 based on USP <51> and EP Medical Devices, Drugs Medical & Surgical Face Masks Textiles, Gloves Bacterial Endotoxins Bacterial Filtration Efficiency (BFE) Viral Filtration Efficiency (VFE) Barrier Testing (Viral Penetration) STP0046 based on USP <85>, USP<161>, USP<797>, AAMI ST72, EP , ASTM D , BS EN STP00004 and STP0007 based on ASTM F2101, EN14683, ASTM F2100 STP0062 and STP0174 based on ASTM F1671, AAMI PB70, ISO16604 Microplate Reader Andersen Sampler ISO Class 5 Hoods Textiles, Medical Devices, Tissues, Pharmaceuticals Bioburden STP0036 based on ISO , STP0050 based on ISO , and -02, AAMI TIR 17, 35, 37, STP0051 based on ISO and -02, and -02, AAMI TIR 17, 33, 37 and STP0044 based on ISO and -02, AAMI TIR 33, 35 ISO Class 5 Hoods Version 003 Issued: 03/14/2017 Page 1 of 4

4 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 to -4, ISO to -2, ISO 14161, ISO 14937, ISO , AAMI TIR 13, 14, 16, BS EN 550 BI Sterility Suite ISO Class 5 Hoods Incubator Medical Devices, Reusable Devices Cleaning, Disinfection, Sterilization Including the following subanalyses (separately accredited): Hemoglobin Protein Carbohydrates MEM elution TOC Bioburden STP0083and STP0129 based on AAMI TIR 12, 30, ASTM E1837, ISO17664 STP0086 based on ANSI/AAMI ST79, AAMITIR12, ANSI/AAMI/ISO 17665, USP <1211> STP0152 based on AAMI TIR 12, USP<1211>, ANSI/AAMI/ ISO 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) UV/VIS Spectrophotometer 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 Medical Devices, Raw Materials Hemolysis STP0093 based on ANSI/AAMI/ISO ,4,12 and ASTM F Spectrophotometer Medical Devices, Raw Materials Filters Medical Devices, Pharmaceuticals Medical Devices, Pharmaceuticals MEM Elution Microbial Retention (Including Filter Bubble Point/Integrity Test) Microbiological Examination of NonSterile Products (Enumeration and Specified Organisms, USP 61/62) Organism Identification (Genetic and Gram Stain) STP0032 based on ANSI/AAMI/ ISO ,5,12 USP <87>, USP<1031> STP0103 based on ASTM F STP0169 and STP0165 based on USP<61> and USP<62> STP0105, STP0173 and STP0037 based on USP<1113> ISO Class 5 Hoods Microscope Flow Meter Pressure Gauge ISO Class 5 Hood ISO Class 5 Hoods Genetic Sequencers Thermocyclers Automatic Gram Stainer ISO Class 5 Hoods Microscopes Version 003 Issued: 03/14/2017 Page 2 of 4

5 Items, Materials or Products Tested Specific tests or Properties Measured Specification, Standard Method, or Technique Used Key Equipment or Technology* Medical Devices, Pharmaceuticals, Biologics, Tissues Product Sterility & Bacteriostasis /Fungistasis (B/F) STP0077 and STP0078 based on USP<71>, USP<161>, USP<797>, ISO , and -02, PIC/S PI 012-3, EP 2.6.1, JP V 4.06, ISO 17665, AAMI TIR 33 ISO Class 5 Cleanrooms and Hoods Water, Food, Cosmetics, Pharmaceuticals Standard Plate Counts STP-0035 based on USP <71> STP0169 based on USP<61> ISO Class 5 Hoods Physical/ Chemical Testing Items, Materials or Products Tested Specific tests or Properties Measured Specification, Standard Method, or Technique Used Key Equipment or Technology* 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 Packaging Materials for Medical Device & Pharmaceutical Container Closure (Dye Ingress) STP0149 based on ANSI/AAMI/ISO ,2, ASTM D , 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/ISO , 2008, USP <621> Gas Chromatograph (GC) Polymers, Non-volatile Residue, Materials FTIR, Characterization Material STP0021 based on USP<851>and USP<197> FTIR Spectrophotometer Medical Devices, Injectables and Ophthalmic Solutions, Pharmaceutical Products Particulates STP0011 based on USP <788>, <789>, EP , , BP Appendix III A, BH EN , ISO Liquid Particle Counter Microscope Medical & Surgical Face Masks Particulate Efficiency (PFE) Filtration STP0005 based on ASTM F2299 Particle Generator Particle Counter Respirators Respirator Certification Testing (NIOSH N95/N99) Respirator Inhalation/Exhalatio n Respirator Valve Leak Version 003 Issued: 03/14/2017 Page 3 of 4 STP 145 based on 42 CFR Part 84 and NIOSH TEB APR-STP-007, RCT- APR-STP-003 STP0143 based on 42 CFR Part 84 and NIOSH TEB-APR-STP-0004 Differential Pressure Apparatus Air Flow Apparatus Automated Filter Tester

Items, Materials or Products Tested Specific tests or Properties Measured Specification, Standard Method, or Technique Used Key Equipment or Technology* Sodium Chloride Aerosol Test STP0014 based on

6 Items, Materials or Products Tested Specific tests or Properties Measured Specification, Standard Method, or Technique Used Key Equipment or Technology* Sodium Chloride Aerosol Test STP0014 based on 42 CFR Part 84and NIOSH TEB-ARP-STP- 0058, TEB-ARP-STP-0059 Water USP, Water EP Water Purity Analysis TOC Conductivity ph STP0024 and STP0099 based on USP<1231>, USP<1230> and all USP monograph waters, STP0028 based on USP<643> STP0029 based on USP<791> STP0147 based on USP<645> Ion Analyzer TOC Analyzer Medical Devices, Reusable Devices Biological Marker Analysis Hemoglobin Protein Carbohydrates STP0087, STP0088, STP0089, and STP0183 based on ASTM F756-13, AAMI TIR30, and Cleaning, Disinfection, Sterilization references previously listed. UV/VIS Spectrophotometer Microbiological and Physical/Chemical Testing Items, Materials or Products Tested Medical & Surgical Gowns and Drapes Specific tests or Properties Measured EN 13795: Performance requirements for surgical gowns and drapes Microbial penetration resistance Microbial evaluation (bioburden) Particle evaluation Liquid penetration resistance Burst strength Tensile Strength Specification, Standard Method, or Technique Used STP191 based on EN ISO22610 and EN ISO STP0036 based on ISO (Bioburden method) STP0144 based on EN ISO STP0071 based on AATCC 127 and EN STP0192 based on EN ISO STP0066 EN Key Equipment or Technology* ISO Class 5 Hoods Gelbo Flex Unit Particle counter Burst tester Instron (Tensile) tester Notes: 1. * = As Applicable 2. This scope is formatted as part of a single document including the Certificate of Accreditation No. AT-1382 Version 003 Issued: 03/14/2017 Page 4 of 4

7 Virgil M. McCarthy From: CDRH Registration and Listing Sent: Saturday, October 07, :39 PM To: DeMent, Aaron Subject: Registration Number : Successful 2018 Medical Device Establishment Registration Dear Aaron DeMent: This provides confirmation that the annual registration for the following medical device establishment has been successfully completed for 2018: Registration Number: Owner Operator Number: NELSON LABORATORIES, LLC 6280 S Redwood Rd Salt Lake City, UT UNITED STATES If you do not see a registration number assigned to the establishment and your establishment previously had one, please send an to reglist@cdrh.fda.gov 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, Registration for 2019 will be conducted between October 1 and December 31, 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 to the CDRH Registration and Listing Helpdesk at reglist@cdrh.fda.gov. CDRH Registration and Listing Helpdesk Office of Compliance Center for Devices and Radiological Health U.S. Food and Drug Administration Tel: , Option 1 reglist@cdrh.fda.gov 09 Oct :57 PM

10 12. HCT/Ps REGULATED AS MEDICAL DEVICES 11. HCT/Ps DESCRIBED IN 21 CFR DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps) (See reverse side for instructions) PART I - ESTABLISHMENT INFORMATION 3. OTHER FDA REGISTRATIONS a. BLOOD FDA 2830 b. DEVICES FDA 2891 NO. NO. FEI: FEI: d. INACTIVE PART II - PRODUCT INFORMATION 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps Establishment Functions Types of HCT / Ps See Instructions for OMB Statement. FORM APPROVED:OMB No Expiration Date: 3/31/ REGISTRATION NUMBER 2. REASON FOR SUBMISSION (FDA Establishment Identifier) a. INITIAL REGISTRATION / LISTING b. ANNUAL REGISTRATION / LISTING c. CHANGE IN INFORMATION Recover Screen Test Package Process Store Label Distribute VALIDATION--FOR FDA USE ONLY VALIDATED BY FDA:19-NOV-2016 DISTRICT: Denver PRINTED BY FDA:15-DEC HCT/Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS 14. PROPRIETARY NAME(S) 1 c. DRUG FDA 2656 NO. FEI: PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code) Nelson Laboratories, LLC a. Bone b. Cartilage 6280 South Redwood Road Salt Lake City, Utah c. Cornea d. Dura Mater a. PHONE ET b. SATELLITE RECOVERY ESTABLISHMENT (MANUFACTURING ESTABLISHMENT FEI NO. c. TESTING FOR MICRO-ORGANISMS ONLY 5. ENTER CORRECTIONS TO ITEM 4 e. Embryo f. Fascia g. Heart Valve h. Ligament SIP Directed Anonymous 6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code) Nelson Laboratories, LLC Attn: Matthew D. Cushing, BS 6280 South Redwood Road Salt Lake City, Utah i. Oocyte j. Pericardium k. Peripheral Blood Stem SIP Directed Anonymous Autologous Family Related Allogeneic l. Sclera a. PHONE ET 7. ENTER CORRECTIONS TO ITEM 6 b. PHONE m. Semen n. Skin SIP Directed Anonymous o. Somatic Cell Therapy Products Autologous Family Related Allogeneic 8. U.S. AGENT p. Tendon a. 9. REPORTING OFFICIAL'S SIGNATURE a. TYPED NAME Matthew D. Cushing, BS b. MCushing@nelsonlabs.com c. TITLE Director of Regulatory Affairs FORM FDA (5/14) d. DATE 18-NOV-2016 q. Umbilical Cord Blood r. Vascular Graft s. t. u. v. Autologous Family Related Allogeneic

11 1, 2

RN0504274 1,2,2N 3,3N,4,5 10-31-2018 ANALYTICAL LAB $244.

15 RN ,2,2N 3,3N,4, ANALYTICAL LAB $ NELSON LABORATORIES, LLC 6280 SOUTH REDWOOD RD SALT LAKE CITY, UT RN ,2,2N 3,3N,4, ANALYTICAL LAB NELSON LABORATORIES, LLC 6280 SOUTH REDWOOD RD SALT LAKE CITY, UT $

Certifications: Table of Contents. Document # Title Page(s)

Certifications: Table of Contents Document # Title Page(s) 1 ISO 17025: Certificate of Accreditation 2 2 ISO 17025: Scope of Accreditation 3-7 3 FDA: Medical Device Establishment 8 Registration 4 FDA: