Bayer Health Care
Form 483 issued July 30, 2015 · Shawnee, Kansas
- Inspection
- Jul 21 – Jul 30, 2015
- Investigator
- Michele L. Obert
- Observations
- 2
- Pages
- 1
- FEI number
- 1910953
In short: On July 30, 2015, FDA issued a Form 483 with 2 observations to Bayer Health Care in Shawnee, Kansas (FEI 1910953) after an inspection that ran Jul 21 – Jul 30, 2015. The investigator was Michele L. Obert. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
This inspection in context
Michele L. Obert
6 documents · 2012–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmBayer Health Care history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bayer Health Care?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Bayer Health Care?
Michele L. Obert is named on this Form 483, for the inspection of Jul 21 – Jul 30, 2015. Each investigator has a profile showing what they cite most.
When was Bayer Health Care inspected by FDA?
The inspection ran Jul 21 – Jul 30, 2015, and the Form 483 is dated July 30, 2015.
How do I get the full Form 483 for Bayer Health Care?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.