FDA Inspection 798757 — CEMI International, Inc.
The FDA completed an inspection of CEMI International, Inc. on September 6, 2012 in Orlando, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 6, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |
| 16020 | 21 CFR 111.140 (b)(3)(ii) | Material review, disposition, follow-up; investigation |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |