FDA Inspection
Debut Development, LLCDebut Development, LLC – FDA Inspection, Sep 20, 2018
Record Details
This FDA Inspection record concerns Debut Development, LLC, with an inspection on September 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4eff8dba-3b97-419c-951d-860a1bd666e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066135
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.182Written records kept in individual logs
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