FDA Inspection 1021791 — Vapco Incorporated
The FDA completed an inspection of Vapco Incorporated on August 16, 2017 in Lawrence, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 16, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Lawrence, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |