Sovereign Pharmaceuticals, LLC
Form 483 issued August 2, 2023 · Fort Worth, Texas
- Investigators
- A. Ol· Christopher N. Tran
- Observations
- 3
- Pages
- 6
- FEI number
- 3003229412
In short: On August 2, 2023, FDA issued a Form 483 with 3 observations to Sovereign Pharmaceuticals, LLC in Fort Worth, Texas (FEI 3003229412). The investigators were A. Ol and Christopher N. Tran. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
Component testing is deficient in that each component is not tested for conformity with all appropriate…
This inspection in context
A. Ol
1 document · 2023
Cites 211.160 (general requirements) 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
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 materials. The opening words of each observation are shown on this page.
Who inspected Sovereign Pharmaceuticals, LLC?
A. Ol and Christopher N. Tran are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Sovereign Pharmaceuticals, LLC inspected by FDA?
This Form 483 is dated August 2, 2023.
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.