FDA Inspection 1175495 — Renu Laboratories, Inc.
The FDA completed an inspection of Renu Laboratories, Inc. on July 27, 2022 in Warminster, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Warminster, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |