FDA Intel

Bayer HealthCare, LLC

Form 483 issued August 26, 2022 · Berkeley, California

Inspection
Aug 15 – Aug 26, 2022
Investigator
Christopher R. Czajka
Observations
3
Pages
5
FEI number
2910913

In short: On August 26, 2022, FDA issued a Form 483 with 3 observations to Bayer HealthCare, LLC in Berkeley, California (FEI 2910913) after an inspection that ran Aug 15 – Aug 26, 2022. The investigator was Christopher R. Czajka. Most observations concern production and facilities & equipment.

At a glance

2 of 3 observations on this 483 concern production.

Production2
Facilities & equipment1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.67(b)

    Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…

  2. 02
    21 CFR 211.100(b)

    Deviations from written production and process control…

  3. 03
    21 CFR 211.28(a)

    Protective apparel is not worn as necessary to protect…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Christopher R. Czajka

37 documents · 2015–2025

Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.

The firm

Bayer HealthCare, LLC history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.67(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Bayer HealthCare, LLC?

FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.

Who inspected Bayer HealthCare, LLC?

Christopher R. Czajka is named on this Form 483, for the inspection of Aug 15 – Aug 26, 2022. Each investigator has a profile showing what they cite most.

When was Bayer HealthCare, LLC inspected by FDA?

The inspection ran Aug 15 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.

How do I get the full Form 483 for Bayer HealthCare, LLC?

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