FDA Inspection 1230344 — Millstone Medical Testing - CT, LLC
The FDA completed an inspection of Millstone Medical Testing - CT, LLC on February 15, 2024 in Willington, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 15, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Willington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |