FDA Inspection 788941 — Oasis Medical, Inc.
The FDA completed an inspection of Oasis Medical, Inc. on June 26, 2012 in Glendora, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendora, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |