FDA Inspection 632621 — Unette Corp
The FDA completed an inspection of Unette Corp on Dec 30, 2009 in Randolph, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 30, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Randolph, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |