FDA Inspection 1167657 — Fagron Compounding Services
The FDA completed an inspection of Fagron Compounding Services on Mar 24, 2022 in Wichita, KS. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 24, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |