Sovereign Pharmaceuticals, LLC
Form 483 issued April 22, 2022 · Fort Worth, Texas
- Inspection
- Apr 13 – Apr 22, 2022
- Investigator
- Adaris Mas Rivera
- Observations
- 4
- Pages
- 6
- FEI number
- 3003229412
In short: On April 22, 2022, FDA issued a Form 483 with 4 observations to Sovereign Pharmaceuticals, LLC in Fort Worth, Texas (FEI 3003229412) after an inspection that ran Apr 13 – Apr 22, 2022. The investigator was Adaris Mas Rivera. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not drafted, reviewed and approved by…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Adaris Mas Rivera
1 document · 2022
Cites 211.100(a) (written procedures; deviations) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sovereign Pharmaceuticals, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Sovereign Pharmaceuticals, LLC?
Adaris Mas Rivera is named on this Form 483, for the inspection of Apr 13 – Apr 22, 2022. Each investigator has a profile showing what they cite most.
When was Sovereign Pharmaceuticals, LLC inspected by FDA?
The inspection ran Apr 13 – Apr 22, 2022, and the Form 483 is dated April 22, 2022.
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.