FDA Inspection 743880 — Apace Packaging LLC
The FDA completed an inspection of Apace Packaging LLC on September 23, 2011 in Fountain Run, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 16 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Fountain Run, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4329 | 21 CFR 211.122(b) | Rejection of unapproved labeling/packaging materials |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |