Boehringer Ingelheim Fremont, Inc.
FDA inspection history in Fremont, California, 2017 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18Two Form 483s, at Fremont, California.
- 2017The longest 483 on file: 10 observations over 4 pages at Fremont, California.
- 2022One Form 483, at Fremont, California.
Cited most
Across all Boehringer Ingelheim Fremont observations on file
- 21 CFR 211.160General requirements6
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
The complete Boehringer Ingelheim Fremont file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fremont, California
Three Form 483s · 2017 to 2022 · 16 observations
Latest: Form 483, Nov 4, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-04 | 483 Form 483 | Fremont, California | 1 | $99 |
| 2018-08-24 | 483 Form 483 | Fremont, California | 5 | $99 |
| 2017-04-04 | 483 Form 483 | Fremont, California | 10 | $99 |
Investigators on these documents
Anita Narula (1)Christopher R. Czajka (1)Diane Raccasi (1)Ephrem Hunde (1)Jeffrey P. Raimondi (1)Kristin M. Abaonza (1)Marcus F. Yambot (1)Maria Cruz-Fisher (1)Monica Commerford (1)Richard Ledwidge (1)Tracy Denison (1)
FEI number 3005925062 · most recent document Nov 4, 2022
About Boehringer Ingelheim Fremont, Inc.
How many FDA Form 483s has Boehringer Ingelheim Fremont, Inc. received?
FDA Intel has 3 Form 483s on file for Boehringer Ingelheim Fremont, Inc.; the most recent is dated Nov 4, 2022.
When was Boehringer Ingelheim Fremont, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Boehringer Ingelheim Fremont, Inc. is a Form 483 dated Nov 4, 2022, for the site in Fremont, California.
What did FDA cite at Boehringer Ingelheim Fremont, Inc.?
The regulations cited most in the observations on file for Boehringer Ingelheim Fremont, Inc. are 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.