FDA Inspection 702279 — Graphic Controls Acquisition Corporation
The FDA completed an inspection of Graphic Controls Acquisition Corporation on December 16, 2010 in Buffalo, NY. 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
- December 16, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 4203 | 21 CFR 806.10(c)(10) | Date of manufacture, dist., expiration |