AltaThera Pharmaceuticals LLC
Form 483 issued September 19, 2019 · Chicago, Illinois
- Inspection
- Sep 17 – Sep 19, 2019
- Investigators
- Alan M. Roberts· Peng Zhou
- Observations
- 1
- Pages
- 3
- FEI number
- 3013989010
In short: On September 19, 2019, FDA issued a Form 483 with 1 observation to AltaThera Pharmaceuticals LLC in Chicago, Illinois (FEI 3013989010) after an inspection that ran Sep 17 – Sep 19, 2019. The investigators were Alan M. Roberts and Peng Zhou. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed and…
This inspection in context
Alan M. Roberts
4 documents · 2019–2021
Cites 211.22(a) (responsibilities of quality control unit) 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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AltaThera Pharmaceuticals LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected AltaThera Pharmaceuticals LLC?
Alan M. Roberts and Peng Zhou are named on this Form 483, for the inspection of Sep 17 – Sep 19, 2019. Each investigator has a profile showing what they cite most.
When was AltaThera Pharmaceuticals LLC inspected by FDA?
The inspection ran Sep 17 – Sep 19, 2019, and the Form 483 is dated September 19, 2019.
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.