FDA Inspection
Bayer Healthcare Manufacturing SrlBayer Healthcare Manufacturing Srl – FDA Inspection, Apr 3, 2009
Record Details
This FDA Inspection record concerns Bayer Healthcare Manufacturing Srl, with an inspection on April 3, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 3, 2009
- Product Type
- Drugs
View Company Profile
ID · 00cc742e-5e25-4475-8ca4-ef2bcbfbf359
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 583049
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bayer Healthcare Manufacturing Srl
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bayer Healthcare Manufacturing Srl
- FDA Inspection 1270855 - 2023-07-20
- FDA Inspection 1133402 - 2019-04-19
- FDA Inspection 947913 - 2015-10-16
- FDA Inspection 826683 - 2013-03-15
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.