FDA Inspection 773429 — S.A.E.G.
The FDA completed an inspection of S.A.E.G. on March 19, 2012 in Owingsville, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 19, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Owingsville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3563 | 21 CFR 211.56(c) | Rodenticides et. al. registration and usage |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |