Bayer Health Care
FDA inspection history in Shawnee, Kansas, 2015 to 2016
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, at Shawnee, Kansas.
- 2015The longest 483 on file: 2 observations over 1 pages at Shawnee, Kansas.
Cited most
Across all Bayer Health Care observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
The complete Bayer Health Care 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
Shawnee, Kansas
Two Form 483s · 2015 to 2016 · 3 observations
Latest: Form 483, Aug 15, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-15 | 483 Form 483 | Shawnee, Kansas | 1 | $99 |
| 2015-07-30 | 483 Form 483 | Shawnee, Kansas | 2 | $99 |
Investigators on these documents
FEI number 1910953 · most recent document Aug 15, 2016
About Bayer Health Care
How many FDA Form 483s has Bayer Health Care received?
FDA Intel has 2 Form 483s on file for Bayer Health Care; the most recent is dated Aug 15, 2016.
When was Bayer Health Care last inspected by FDA?
The most recent FDA inspection document on file for Bayer Health Care is a Form 483 dated Aug 15, 2016, for the site in Shawnee, Kansas.
What did FDA cite at Bayer Health Care?
The regulations cited most in the observations on file for Bayer Health Care are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.