FDA Inspection 653633 — Agropharma Laboratories Inc.
The FDA completed an inspection of Agropharma Laboratories Inc. on May 7, 2010 in Salinas, PR. 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
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Salinas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |