Athea Laboratories Inc.
Form 483 issued January 25, 2017 · Milwaukee, Wisconsin
- Inspection
- Jan 23 – Jan 25, 2017
- Investigator
- Ross J. Grigsby
- Observations
- 2
- Pages
- 2
- FEI number
- 3010165256
In short: On January 25, 2017, FDA issued a Form 483 with 2 observations to Athea Laboratories Inc. in Milwaukee, Wisconsin (FEI 3010165256) after an inspection that ran Jan 23 – Jan 25, 2017. The investigator was Ross J. Grigsby. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.165(f) (1×) · 211.42(c)(7) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
Ross J. Grigsby
8 documents · 2017–2021
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Minnesota.
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 211.165(f)
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 laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Athea Laboratories Inc.?
Ross J. Grigsby is named on this Form 483, for the inspection of Jan 23 – Jan 25, 2017. Each investigator has a profile showing what they cite most.
When was Athea Laboratories Inc. inspected by FDA?
The inspection ran Jan 23 – Jan 25, 2017, and the Form 483 is dated January 25, 2017.
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.