FDA Inspection
Ampharmco LLCAmpharmco LLC – FDA Inspection, Dec 12, 2012
Record Details
This FDA Inspection record concerns Ampharmco LLC, with an inspection on December 12, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Ampharmco LLC
- Inspection Date
- December 12, 2012
- Product Type
- Veterinary
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ID · c2e4d7cf-0b69-4f09-90b0-caf0eeafbb40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811514
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(b)(5)Calculated Excess of Components Used
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Ampharmco LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | Not classified | Dallas District Office | |
| November 8, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2019 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| June 21, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 2, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ampharmco LLC
- FDA Inspection 1267273 - 2025-03-07
- FDA Inspection 1157983 - 2021-11-08
- FDA Inspection 1085120 - 2019-03-27
- FDA Inspection 1056393 - 2018-06-21
- FDA Inspection 970069 - 2016-05-02
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