FDA Inspection 760463 — Seatex LLC
The FDA completed an inspection of Seatex LLC on January 23, 2012 in Rosenberg, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 23, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rosenberg, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |