FDA Inspection 945864 — MGM Instruments
The FDA completed an inspection of MGM Instruments on Oct 7, 2015 in Hamden, CT. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 7, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Hamden, CT (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |