FDA Inspection 1075861 — Analys Lab Private Limited
The FDA completed an inspection of Analys Lab Private Limited on Dec 21, 2018 in Secunderabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 21, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Secunderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |