FDA Inspection 970033 — Agropharma Laboratories Inc.
The FDA completed an inspection of Agropharma Laboratories Inc. on Feb 12, 2016 in Salinas, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Salinas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15563 | 21 CFR 111.260(l)(1)(i) | Batch record - quality control review; monitoring |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |