FDA Inspection 561962 — Fagron, Inc
The FDA completed an inspection of Fagron, Inc on Feb 11, 2009 in Saint Paul, MN. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |