FDA Inspection 1088808 — Medical Components Specialists
The FDA completed an inspection of Medical Components Specialists on May 7, 2019 in Bellingham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bellingham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |