FDA Inspection 1119942 — Sterimax, Inc.
The FDA completed an inspection of Sterimax, Inc. on Mar 6, 2020 in Oakville. 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 6, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakville (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |