FDA Inspection 730758 — Ranbaxy Inc.
The FDA completed an inspection of Ranbaxy Inc. on June 22, 2011 in Princeton, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Princeton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6736 | 21 CFR 314.80(c)(1)(ii) | Submission of report follow-up |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |