FDA Inspection
NingBo Huize Commodity Co.,Ltd.NingBo Huize Commodity Co.,Ltd. – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns NingBo Huize Commodity Co.,Ltd., with an inspection on March 22, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 26e639a6-73f3-4b13-9640-8e006c157692
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1085069
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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