FDA Inspection 913357 — Bio Essence Corporation
The FDA completed an inspection of Bio Essence Corporation on Feb 9, 2015 in San Leandro, 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 9, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Leandro, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15579 | 21 CFR 111.155(c)(1) | Components - representative samples |
| 15606 | 21 CFR 111.165(c)(1) | Product received - quarantine; representative samples |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |