FDA Inspection 1065533 — SwissCo Services AG
The FDA completed an inspection of SwissCo Services AG on September 14, 2018 in Sisseln AG. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sisseln AG (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |