FDA Inspection 1084965 — GC America, Inc.
The FDA completed an inspection of GC America, Inc. on March 28, 2019 in Alsip, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alsip, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |