FDA Inspection 1065349 — A.C. Calderoni & Co. Inc.
The FDA completed an inspection of A.C. Calderoni & Co. Inc. on September 6, 2018 in Brisbane, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 6, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Brisbane, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12744 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures - none listed |
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 12748 | 21 CFR 120.8(b)(5) | HACCP plan - corrective action plan not included |
| 12755 | 21 CFR 120.11(a)(1)(iv) | Records - not signed and dated by qualified individual |
| 9986 | 21 CFR 120.24(c) | Process controls - not exempt, single facility |