FDA Inspection 848808 — Dr. Reddy's Laboratories Louisiana LLC
The FDA completed an inspection of Dr. Reddy's Laboratories Louisiana LLC on September 6, 2013 in Shreveport, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 6, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shreveport, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |