AltaThera Pharmaceuticals LLC
Form 483 issued June 17, 2022 · Chicago, Illinois
- Inspection
- Jun 10 – Jun 17, 2022
- Investigators
- Colleen E. Burke· Jeanne J. Thai· Yuanyuan Li
- Observations
- 4
- Pages
- 4
- FEI number
- 3013989010
In short: On June 17, 2022, FDA issued a Form 483 with 4 observations to AltaThera Pharmaceuticals LLC in Chicago, Illinois (FEI 3013989010) after an inspection that ran Jun 10 – Jun 17, 2022. The investigators were Colleen E. Burke, Jeanne J. Thai and Yuanyuan Li. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
You failed to maintain for a period of 10 years records of all adverse drug experiences…
- 02
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of…
- 03
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the…
- 04
An annual report was not submitted within 60 days of the anniversary date of U.S. approval…
This inspection in context
Colleen E. Burke
1 document · 2022
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in Illinois.
The firmAltaThera Pharmaceuticals 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 314.80(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AltaThera Pharmaceuticals LLC?
FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected AltaThera Pharmaceuticals LLC?
Colleen E. Burke, Jeanne J. Thai and Yuanyuan Li are named on this Form 483, for the inspection of Jun 10 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was AltaThera Pharmaceuticals LLC inspected by FDA?
The inspection ran Jun 10 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
How do I get the full Form 483 for AltaThera Pharmaceuticals 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.