FDA Inspection 966852 — CHEMATICS, INC.
The FDA completed an inspection of CHEMATICS, INC. on April 15, 2016 in Leesburg, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 15, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leesburg, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |