FDA Inspection 820670 — Agropharma Laboratories Inc.
The FDA completed an inspection of Agropharma Laboratories Inc. on March 20, 2013 in Salinas, PR. 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
- March 20, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Salinas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15788 | 21 CFR 111.410(a) | Packaging - specifications |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |