FDA Inspection 982362 — World Club Supply Corp
The FDA completed an inspection of World Club Supply Corp on August 18, 2016 in Orange, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 18, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orange, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |