FDA Inspection 1101641 — Medipro Pharmaceuticals Co., Ltd.
The FDA completed an inspection of Medipro Pharmaceuticals Co., Ltd. on August 30, 2019 in Shanghai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Shanghai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15506 | 21 CFR 111.27(a)(4) | Equipment - bonded seams |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15586 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15651 | 21 CFR 111.465(a)(2) | Hold - reserve sample; closure system- packaged, labeled |
| 15671 | 21 CFR 111.315 | Laboratory control processes - requirements |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15803 | 21 CFR 111.560(c) | Product complaint -investigate, findings, follow-up |