FDA Inspection 979389 — Marco Pharma International, LLC
The FDA completed an inspection of Marco Pharma International, LLC on June 17, 2016 in Roseburg, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 17, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Roseburg, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |