FDA Inspection 1062631 — FDC Limited
The FDA completed an inspection of FDC Limited on August 16, 2018 in Aurangabad, Maharashtra State. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 16, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aurangabad, Maharashtra State (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |