FDA Inspection 1050548 — Monsoon Beverages LLC
The FDA completed an inspection of Monsoon Beverages LLC on May 1, 2018 in Tempe, AZ. 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). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15535 | 21 CFR 111.255(d) | Batch record - 1 year, 2 years |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 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 |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |