FDA Inspection 1165937 — Swiss American CDMO, LLC
The FDA completed an inspection of Swiss American CDMO, LLC on March 31, 2022 in Carrollton, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3574 | 21 CFR 211.101(b)(1) | Subdivided component container identification |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |