FDA Inspection 1165160 — Frezco Beverages
The FDA completed an inspection of Frezco Beverages on March 23, 2022 in Nadi. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 23, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Nadi (Fiji)
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12749 | 21 CFR 120.8(b)(6) | HACCP plan - verify procedures / frequency - none listed |
| 15539 | 21 CFR 111.260(a)(1) | Batch record - control number, finished batch |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |