FDA Inspection 1065809 — Agropharma Laboratories Inc.
The FDA completed an inspection of Agropharma Laboratories Inc. on September 14, 2018 in Salinas, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salinas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |