FDA Inspection 931772 — CDSM LLC
The FDA completed an inspection of CDSM LLC on June 23, 2015 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 23, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 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 |
| 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 |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |