Bayer HealthCare, LLC
FDA inspection history in Berkeley, California, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Berkeley, California.
- 2019The longest 483 on file: 6 observations over 4 pages at Berkeley, California.
- 2022One Form 483, at Berkeley, California.
Cited most
Across all Bayer HealthCare observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.192Production record review1
The complete Bayer HealthCare file.
All 2 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
Berkeley, California
Two Form 483s · 2019 to 2022 · 9 observations
Latest: Form 483, Aug 26, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-26 | 483 Form 483 | Berkeley, California | 3 | $99 |
| 2019-11-21 | 483 Form 483 | Berkeley, California | 6 | $99 |
Investigators on these documents
FEI number 2910913 · most recent document Aug 26, 2022
About Bayer HealthCare, LLC
How many FDA Form 483s has Bayer HealthCare, LLC received?
FDA Intel has 2 Form 483s on file for Bayer HealthCare, LLC; the most recent is dated Aug 26, 2022.
When was Bayer HealthCare, LLC last inspected by FDA?
The most recent FDA inspection document on file for Bayer HealthCare, LLC is a Form 483 dated Aug 26, 2022, for the site in Berkeley, California.
What did FDA cite at Bayer HealthCare, LLC?
The regulations cited most in the observations on file for Bayer HealthCare, LLC are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.130 (Packaging and labeling operations), 1 time.