FDA Inspection 1093423 — Regenesis Pharmaceutical Inc.
The FDA completed an inspection of Regenesis Pharmaceutical Inc. on June 18, 2019 in Santa Ana, 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
- June 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |