FDA Inspection
North American Science Associates, LLCNorth American Science Associates, LLC – FDA Inspection, May 2, 2024
Record Details
This FDA Inspection record concerns North American Science Associates, LLC, with an inspection on May 2, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Leslie W. Gilbert (Company Rep)
- Tammara A. Stephens (Issuing Officer)
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ID · 002c6dc3-a809-4a07-b3d2-3eab7a8396fe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237556
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.195(a)(1)Temperature and humidity controls
- 21 CFR 1271.250(a)Design of labeling procedures
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.210(c)In-house reagent production
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Other FDA inspections of North American Science Associates, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2026 | Not classified | Atlanta District Office | Human Cellular, Tissue, and Gene Therapies |
| April 11, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 25, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 17, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 27, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for North American Science Associates, LLC
- FDA Inspection 1334818 - 2026-09-08
- FDA Inspection 1088400 - 2019-04-11
- FDA Inspection 1081732 - 2019-01-25
- FDA Inspection 981444 - 2016-08-17
- FDA Inspection 893020 - 2014-08-27
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