FDA Inspection
Guangzhou Haishi Biological Technology Co., Ltd.Guangzhou Haishi Biological Technology Co., Ltd. – FDA Inspection, Jul 24, 2015
Record Details
This FDA Inspection record concerns Guangzhou Haishi Biological Technology Co., Ltd., with an inspection on July 24, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 24, 2015
- Product Type
- Drugs
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ID · e6fc5a10-084c-4bb3-8d74-328ab8e9306b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 937019
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.34Consultant Records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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