FDA Inspection
Alcami Carolinas CorporationAlcami Carolinas Corporation – FDA Inspection, Mar 28, 2025
Record Details
This FDA Inspection record concerns Alcami Carolinas Corporation, with an inspection on March 28, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · 567654cb-c6e5-4248-b982-3a531d738d69
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1265163
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
4- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Alcami Carolinas Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2026 | Not classified | Atlanta District Office | Drug Quality Assurance |
| 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 1330734 - 2026-08-11
- 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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