FDA Inspection
Alcami Carolinas CorporationAlcami Carolinas Corporation – FDA Inspection, Jan 31, 2025
Record Details
This FDA Inspection record concerns Alcami Carolinas Corporation, with an inspection on January 31, 2025, issued by the Atlanta District Office, covering biologics.
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ID · 5e52a43f-9b6e-4476-8dd8-0f15c73661e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259644
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 211.160(b)(4)Written calibration procedures
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Other FDA inspections of Alcami Carolinas Corporation
13| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | NAI | Atlanta District Office | Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| February 18, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 7, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alcami Carolinas Corporation
- FDA Inspection 1285106 - 2025-09-26
- FDA Inspection 1137604 - 2021-02-18
- FDA Inspection 1101779 - 2019-08-09
- FDA Inspection 1084710 - 2019-03-07
- FDA Inspection 1080667 - 2019-01-29
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