FDA Inspection
Alcami Carolinas CorporationAlcami Carolinas Corporation – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Alcami Carolinas Corporation, with an inspection on December 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 307b3d8f-6463-4519-9ed4-032f6c9773e4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1035015
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Alcami Carolinas Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2026 | Not classified | Atlanta District Office | Pre-Approval Eval. of Animal Drugs and Food Additives |
| February 6, 2026 | VAI | Atlanta District Office | Drug Quality Assurance |
| April 5, 2024 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 29, 2021 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 21, 2019 | Not classified | Atlanta District Office |
Other documents for Alcami Carolinas Corporation
- FDA Inspection 1313488 - 2026-04-22
- FDA Inspection 1301852 - 2026-02-06
- FDA Inspection 1235733 - 2024-04-05
- FDA Inspection 1156156 - 2021-10-29
- FDA Inspection 1083831 - 2019-02-21
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