FDA Inspection 1110582 — Gamma Agro-Medical Processings Private Ltd
The FDA completed an inspection of Gamma Agro-Medical Processings Private Ltd on October 30, 2019 in Pashamylaram. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pashamylaram (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |