FDA Inspection
BioDiagnostic InternationalBioDiagnostic International – FDA Inspection, Feb 27, 2018
Record Details
This FDA Inspection record concerns BioDiagnostic International, with an inspection on February 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f4dedf7e-0e49-44e5-bdd4-00b6e46734c4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1042488
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
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