FDA Inspection
Alcami Carolinas CorporationAlcami Carolinas Corporation – FDA Inspection, Aug 11, 2026
Record Details
This FDA Inspection record concerns Alcami Carolinas Corporation, with an inspection on August 11, 2026, issued by the Atlanta District Office, covering human drugs.
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ID · ae357d34-384e-40e4-a682-e74728b8936b
Inspection Facts
- Inspection number
- 1330734
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
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Other FDA inspections of Alcami Carolinas Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | OAI | Atlanta District Office | Generic Drug Evaluation |
| December 6, 2024 | Not classified | Atlanta District Office | |
| March 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 23, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alcami Carolinas Corporation
- FDA Inspection 1265163 - 2025-03-28
- FDA Inspection 1258354 - 2024-12-06
- FDA Inspection 1201193 - 2023-03-13
- FDA Inspection 903656 - 2014-10-23
- FDA Inspection 732087 - 2011-05-24
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