FDA Inspection
Bayscience Formulators, LLCBayscience Formulators, LLC – FDA Inspection, Feb 29, 2012
Record Details
This FDA Inspection record concerns Bayscience Formulators, LLC, with an inspection on February 29, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Bayscience Formulators, LLC
- Inspection Date
- February 29, 2012
- Product Type
- Drugs
View Company Profile
ID · 689ddffe-0df8-47ae-ab0e-28f29108e9f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769943
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.67(b)Written procedures fail to include
Full citation text and observation details available on the Dashboard.
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 |
| November 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bayscience Formulators, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.