FDA Inspection 832080 — CEMI International, Inc.
The FDA completed an inspection of CEMI International, Inc. on May 8, 2013 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |