FDA Inspection 822566 — Curtis Jacquot dba Pacific BioLogic Co.
The FDA completed an inspection of Curtis Jacquot dba Pacific BioLogic Co. on March 27, 2013 in Concord, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 27, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15772 | 21 CFR 111.415(g) | Representative sample - packaged, labeled dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |