FDA Inspection
CHIA GH LTD.CHIA GH LTD. – FDA Inspection, Nov 30, 2012
Record Details
This FDA Inspection record concerns CHIA GH LTD., with an inspection on November 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- CHIA GH LTD.
- Inspection Date
- November 30, 2012
- Product Type
- Drugs
View Company Profile
ID · ef2c6086-7bf1-4211-bca7-42b504001b30
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 811151
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
19- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.165(a)Testing and release for distribution
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