Sovereign Pharmaceuticals, LLC
Form 483 issued September 1, 2021 · Fort Worth, Texas
- Inspection
- Aug 24 – Sep 1, 2021
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 4
- FEI number
- 3003229412
In short: On September 1, 2021, FDA issued a Form 483 with 3 observations to Sovereign Pharmaceuticals, LLC in Fort Worth, Texas (FEI 3003229412) after an inspection that ran Aug 24 – Sep 1, 2021. The investigator was Patty P. Kaewussdangkul. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The master production and control records are deficient in that they do…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmSovereign Pharmaceuticals, LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sovereign Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Sovereign Pharmaceuticals, LLC?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Aug 24 – Sep 1, 2021. Each investigator has a profile showing what they cite most.
When was Sovereign Pharmaceuticals, LLC inspected by FDA?
The inspection ran Aug 24 – Sep 1, 2021, and the Form 483 is dated September 1, 2021.
How do I get the full Form 483 for Sovereign 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.