FDA Inspection 849698 — STERIS Laboratories, Inc.
The FDA completed an inspection of STERIS Laboratories, Inc. on Sep 13, 2013 in Brooklyn Park, MN. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brooklyn Park, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |