FDA Inspection
Green Pharmaceutical Co., Ltd.Green Pharmaceutical Co., Ltd. – FDA Inspection, Aug 31, 2018
Record Details
This FDA Inspection record concerns Green Pharmaceutical Co., Ltd., with an inspection on August 31, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8c235b93-fe0c-4241-b375-a76083519062
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065030
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
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