FDA Inspection
Wagner Pharma KFTWagner Pharma KFT – FDA Inspection, Feb 19, 2015
Record Details
This FDA Inspection record concerns Wagner Pharma KFT, with an inspection on February 19, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wagner Pharma KFT
- Inspection Date
- February 19, 2015
- Product Type
- Drugs
View Company Profile
ID · 24bd3816-bb3a-4969-835d-24c10a423a7c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917841
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
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