FDA Inspection
Bayscience Formulators, LLCBayscience Formulators, LLC – FDA Inspection, Aug 9, 2018
Record Details
This FDA Inspection record concerns Bayscience Formulators, LLC, with an inspection on August 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 23584144-64f3-4218-9af8-9141d358eae5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1062824
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Bayscience Formulators, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 29, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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