FDA Inspection
BODE Chemie GmbHBODE Chemie GmbH – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns BODE Chemie GmbH, with an inspection on September 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 09e6c4f6-0db2-4260-8331-7d5396d0fced
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027015
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of BODE Chemie GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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