FDA Inspection
Bioforce AGBioforce AG – FDA Inspection, Aug 23, 2019
Record Details
This FDA Inspection record concerns Bioforce AG, with an inspection on August 23, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Yumi J. Hiramine (Issuing Officer)
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ID · 94f999ba-dcd1-4fae-bcb0-82d7f8db36c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100901
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.67(b)Written procedures fail to include
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