Bayer Health Care
Form 483 issued August 15, 2016 · Shawnee, Kansas
- Inspection
- Aug 3 – Aug 15, 2016
- Investigator
- Veronica Fuentes
- Observations
- 1
- Pages
- 1
- FEI number
- 1910953
In short: On August 15, 2016, FDA issued a Form 483 with 1 observation to Bayer Health Care in Shawnee, Kansas (FEI 1910953) after an inspection that ran Aug 3 – Aug 15, 2016. The investigator was Veronica Fuentes. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Veronica Fuentes
22 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bayer Health Care?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Bayer Health Care?
Veronica Fuentes is named on this Form 483, for the inspection of Aug 3 – Aug 15, 2016. Each investigator has a profile showing what they cite most.
When was Bayer Health Care inspected by FDA?
The inspection ran Aug 3 – Aug 15, 2016, and the Form 483 is dated August 15, 2016.
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.