FDA Inspection 1026865 — Renu Laboratories, Inc.
The FDA completed an inspection of Renu Laboratories, Inc. on September 19, 2017 in Warminster, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Warminster, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |