FDA Inspection 811514 — Ampharmco LLC
The FDA completed an inspection of Ampharmco LLC on December 12, 2012 in Fort Worth, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2012
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2201 | 21 CFR 211.186(b)(5) | Calculated Excess of Components Used |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |