FDA Inspection 838284 — Nostrum Laboratories, Inc.
The FDA completed an inspection of Nostrum Laboratories, Inc. on June 28, 2013 in Bryan, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bryan, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |