Athea Laboratories Inc.
Form 483 issued December 20, 2023 · Milwaukee, Wisconsin
- Inspection
- Dec 18 – Dec 20, 2023
- Investigator
- Peng Zhou
- Observations
- 2
- Pages
- 4
- FEI number
- 3010165256
In short: On December 20, 2023, FDA issued a Form 483 with 2 observations to Athea Laboratories Inc. in Milwaukee, Wisconsin (FEI 3010165256) after an inspection that ran Dec 18 – Dec 20, 2023. The investigator was Peng Zhou. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(5) (1×) · 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmAthea Laboratories Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Athea Laboratories Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Athea Laboratories Inc.?
Peng Zhou is named on this Form 483, for the inspection of Dec 18 – Dec 20, 2023. Each investigator has a profile showing what they cite most.
When was Athea Laboratories Inc. inspected by FDA?
The inspection ran Dec 18 – Dec 20, 2023, and the Form 483 is dated December 20, 2023.
How do I get the full Form 483 for Athea Laboratories Inc.?
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.