FDA Inspection 1091383 — Marco Pharma International, LLC
The FDA completed an inspection of Marco Pharma International, LLC on May 22, 2019 in Roseburg, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 22, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Roseburg, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16074 | 21 CFR 111.35(b)(4) | Records - equipment; calibrations, inspections, checks |
| 18398 | 21 CFR 117.4 | Training of employees and records |