FDA Inspection
Atlantic BiologicalsAtlantic Biologicals – FDA Inspection, Jan 14, 2020
Record Details
This FDA Inspection record concerns Atlantic Biologicals, with an inspection on January 14, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Atlantic Biologicals
- Inspection Date
- January 14, 2020
- Product Type
- Drugs
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ID · 3c053be5-ad4b-4208-b648-b11e5a37629d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115004
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Atlantic Biologicals
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2025 | Not classified | Florida District Office |
Other documents for Atlantic Biologicals
- FDA Inspection 1291614 - 2025-09-24
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