FDA Inspection 895138 — Sun Deep Inc.
The FDA completed an inspection of Sun Deep Inc. on Aug 15, 2014 in Hayward, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 15, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |