FDA Inspection 1039323 — Indoco Remedies Limited (Plant I)
The FDA completed an inspection of Indoco Remedies Limited (Plant I) on January 19, 2018 in Verna. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Verna (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |