FDA Inspection
Zhaoke Pharmaceutical (Hefei) Company LimitedZhaoke Pharmaceutical (Hefei) Company Limited – FDA Inspection, Jun 18, 2024
Record Details
This FDA Inspection record concerns Zhaoke Pharmaceutical (Hefei) Company Limited, with an inspection on June 18, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- June 18, 2024
- Product Type
- Human Drugs
View Company Profile
ID · 0434a978-98d1-403e-88cb-9089d094d5fb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1245073
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Backup data not assured as exact and complete
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