FDA Inspection 881607 — Ortho Biologics, LLC
The FDA completed an inspection of Ortho Biologics, LLC on May 23, 2014 in Manati, PR. 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
- May 23, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manati, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |