FDA Inspection
Temmentech AGTemmentech AG – FDA Inspection, Jun 17, 2016
Record Details
This FDA Inspection record concerns Temmentech AG, with an inspection on June 17, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Temmentech AG
- Inspection Date
- June 17, 2016
- Product Type
- Drugs
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ID · 9c67b77a-9ecc-4d6e-9d25-dbdbb5419378
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 982441
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 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 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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