FDA Inspection 802768 — Gland Chemicals Private Limited
The FDA completed an inspection of Gland Chemicals Private Limited on Oct 10, 2012 in Chennai. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 10, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chennai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |