FDA Inspection 768278 — MICROspecialties, LLC
The FDA completed an inspection of MICROspecialties, LLC on February 3, 2012 in Middletown, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Middletown, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |