Bayer Healthcare Manufacturing Srl — FDA Facility Profile
Bayer Healthcare Manufacturing Srl is an FDA-registered facility (FEI 3002806461) located in Garbagnate-Milanese, IT. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jul 20, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 20, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 19, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Oct 16, 2015 | No Action Indicated (NAI) | No citations listed |
| Mar 15, 2013 | No Action Indicated (NAI) | No citations listed |
| Apr 3, 2009 | Voluntary Action Indicated (VAI) | Complete test data included in records (21 CFR 211.194(a)) Written record of investigation incomplete (21 CFR 211.192) Sample identification and other information (21 CFR 211.194(a)(1)) |
Facility details
- Company
- Bayer Healthcare Manufacturing Srl
- Location
- Garbagnate-Milanese (IT)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs