FDA Inspection 832888 — Contacare Ophthalmics & Diagnostics
The FDA completed an inspection of Contacare Ophthalmics & Diagnostics on April 29, 2013 in Dabhasa. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 29, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dabhasa (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |