FDA Inspection 911459 — Gland Chemicals Private Limited
The FDA completed an inspection of Gland Chemicals Private Limited on Feb 4, 2015 in Chennai. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 4, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chennai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |