FDA Inspection
Hanseler AGHanseler AG – FDA Inspection, Oct 21, 2022
Record Details
This FDA Inspection record concerns Hanseler AG, with an inspection on October 21, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hanseler AG
- Inspection Date
- October 21, 2022
- Product Type
- Drugs
View Company Profile
ID · c04c2deb-4b06-4bf4-9e74-3025d1c07657
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1193140
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
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