FDA Inspection 805702 — Raani Corporation
The FDA completed an inspection of Raani Corporation on Oct 30, 2012 in Bedford Park, IL. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bedford Park, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |