FDA Inspection 1158011 — Microbiologics Inc
The FDA completed an inspection of Microbiologics Inc on December 1, 2021 in Saint Cloud, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Cloud, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |