Bayer Pharma AG Kaiser-Wilhelm Allee
Form 483 issued January 20, 2017 · Leverkusen, Germany
- Inspection
- Jan 12 – Jan 20, 2017
- Investigator
- Justin A. Boyd
- Observations
- 1
- Pages
- 9
- FEI number
- 3002806462
In short: On January 20, 2017, FDA issued a Form 483 with 1 observation to Bayer Pharma AG Kaiser-Wilhelm Allee in Leverkusen, Germany (FEI 3002806462) after an inspection that ran Jan 12 – Jan 20, 2017. The investigator was Justin A. Boyd. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmBayer Pharma AG Kaiser-Wilhelm Allee history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bayer Pharma AG Kaiser-Wilhelm Allee?
FDA listed 1 observation on this Form 483, mostly about production. 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 Pharma AG Kaiser-Wilhelm Allee?
Justin A. Boyd is named on this Form 483, for the inspection of Jan 12 – Jan 20, 2017. Each investigator has a profile showing what they cite most.
When was Bayer Pharma AG Kaiser-Wilhelm Allee inspected by FDA?
The inspection ran Jan 12 – Jan 20, 2017, and the Form 483 is dated January 20, 2017.
How do I get the full Form 483 for Bayer Pharma AG Kaiser-Wilhelm Allee?
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.