FDA Inspection 1209338 — Curtis Jacquot dba Pacific BioLogic Co.
The FDA completed an inspection of Curtis Jacquot dba Pacific BioLogic Co. on June 29, 2023 in Concord, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 29, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Concord, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15890 | 21 CFR 111.80(a) | Components packaging, labels used |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |