FDA Inspection
Medipro Pharmaceuticals Co., Ltd.Medipro Pharmaceuticals Co., Ltd. – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Medipro Pharmaceuticals Co., Ltd., with an inspection on August 30, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 993692f3-689d-4326-8016-965eaf81cd4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101641
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
- 21 CFR 111.315Laboratory control processes - requirements
- 21 CFR 111.155(e)Components - contamination, deterioration, mix-ups
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.155(c)Components - quarantine
- 21 CFR 111.365Manufacturing operations - prevent contamination
- 21 CFR 111.560(c)Product complaint -investigate, findings, follow-up
- 21 CFR 111.15(i)Hand-washing facilities
- 21 CFR 111.20(h)Physical plant - screening against pests
- 21 CFR 111.465(a)(2)Hold - reserve sample; closure system- packaged, labeled
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Other FDA inspections of Medipro Pharmaceuticals Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2011 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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