FDA Inspection
Applied Biologics LLCApplied Biologics LLC – FDA Inspection, Apr 18, 2024
Record Details
This FDA Inspection record concerns Applied Biologics LLC, with an inspection on April 18, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 0b65d8ed-e037-487e-b6ca-8a065512f0c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236331
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(b)Written sanitation procedures lacking
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Other FDA inspections of Applied Biologics LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Applied Biologics LLC
- FDA Inspection 1014818 - 2017-03-22
- FDA Inspection 943897 - 2015-09-23
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