FDA Inspection 1256232 — Exel Inc.
The FDA completed an inspection of Exel Inc. on Nov 25, 2024 in Lockbourne, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 25, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lockbourne, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |