596471
Agropharma Laboratories Inc. — FEI 3000203462
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2009
- Fiscal Year
- 2009
- 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 |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1503 | 21 CFR 211.122(c) | Records not kept for each shipment |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |