FDA Inspection
Alcami Carolinas CorporationAlcami Carolinas Corporation – FDA Inspection, Mar 28, 2017
Record Details
This FDA Inspection record concerns Alcami Carolinas Corporation, with an inspection on March 28, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d408881d-752e-4133-a6e7-0498b6dd8a46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009393
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Following/documenting laboratory controls
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Other FDA inspections of Alcami Carolinas Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2024 | Not classified | Kansas City District Office | |
| January 16, 2020 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 14, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 31, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alcami Carolinas Corporation
- FDA Inspection 1252210 - 2024-10-04
- FDA Inspection 1117467 - 2020-01-16
- FDA Inspection 910052 - 2015-01-14
- FDA Inspection 863845 - 2014-01-31
- FDA Inspection 771829 - 2012-02-03
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