FDA Inspection 677000 — Guna Inc.
The FDA completed an inspection of Guna Inc. on August 5, 2010 in Whitehall, PA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Whitehall, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |