FDA Inspection 843771 — Sarkli Repechage Ltd
The FDA completed an inspection of Sarkli Repechage Ltd on Aug 13, 2013 in Secaucus, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 13, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Secaucus, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15995 | 21 CFR 111.127(d) | Quality control operations - packaged, labeled; specifications |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |