FDA Inspection 1069646 — Sun Deep Inc.
The FDA completed an inspection of Sun Deep Inc. on Oct 18, 2018 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 18, 2018
- Fiscal Year
- 2019
- 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 |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4576 | 21 CFR 211.192 | No written record of investigation |