FDA Inspection
Bayscience Formulators, LLCBayscience Formulators, LLC – FDA Inspection, Nov 23, 2015
Record Details
This FDA Inspection record concerns Bayscience Formulators, LLC, with an inspection on November 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bayscience Formulators, LLC
- Inspection Date
- November 23, 2015
- Product Type
- Drugs
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ID · 9993d182-4e19-4dd6-b31a-46f5d01c4b62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955158
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Bayscience Formulators, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2018 | NAI | 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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