Bayer HealthCare, LLC
Form 483 issued November 21, 2019 · Berkeley, California
- Investigator
- Linda Thai
- Observations
- 6
- Pages
- 4
- FEI number
- 2910913
In short: On November 21, 2019, FDA issued a Form 483 with 6 observations to Bayer HealthCare, LLC in Berkeley, California (FEI 2910913). The investigator was Linda Thai. Most observations concern laboratory controls and packaging & labeling; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and packaging & labeling account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures/controls did not assure that correct labels, labeling, and packaging materials were used for drug…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Linda Thai
18 documents · 2014–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmBayer HealthCare, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bayer HealthCare, LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Bayer HealthCare, LLC?
Linda Thai is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Bayer HealthCare, LLC inspected by FDA?
This Form 483 is dated November 21, 2019.
How do I get the full Form 483 for Bayer HealthCare, LLC?
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.