FDA Inspection 859145 — Seatex LLC
The FDA completed an inspection of Seatex LLC on December 20, 2013 in Rosenberg, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rosenberg, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |