FDA Inspection 917560 — Fishman Chemical Of North Carolina, LLC
The FDA completed an inspection of Fishman Chemical Of North Carolina, LLC on Mar 4, 2015 in Tucson, AZ. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |