FDA Inspection
Boehringer Ingelheim Fremont, Inc.Boehringer Ingelheim Fremont, Inc. – FDA Inspection, Feb 25, 2010
Record Details
This FDA Inspection record concerns Boehringer Ingelheim Fremont, Inc., with an inspection on February 25, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 25, 2010
- Product Type
- Drugs
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ID · b12233de-a157-49d1-9735-de1d79f08060
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653544
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
Showing 10 of 12 citations.
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Other FDA inspections of Boehringer Ingelheim Fremont, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2024 | Not classified | San Francisco District Office | |
| April 13, 2023 | Not classified | San Francisco District Office | |
| November 4, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 4, 2017 | Not classified | San Francisco District Office |
Other documents for Boehringer Ingelheim Fremont, Inc.
- FDA Inspection 1263388 - 2024-05-16
- FDA Inspection 1205076 - 2023-04-13
- FDA Inspection 1187410 - 2022-11-04
- FDA Inspection 1063730 - 2018-08-24
- FDA Inspection 1005958 - 2017-04-04
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