FDA Inspection 1014705 — Contacare Ophthalmics & Diagnostics
The FDA completed an inspection of Contacare Ophthalmics & Diagnostics on April 4, 2017 in Dabhasa. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dabhasa (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |