Sovereign Pharmaceuticals, LLC
Form 483 issued August 21, 2015 · Fort Worth, Texas
- Inspection
- Aug 17 – Aug 21, 2015
- Investigators
- Matthew R. Maddox· Scott Ballard· Unnee Ranjan
- Observations
- 3
- Pages
- 2
- FEI number
- 3003229412
In short: On August 21, 2015, FDA issued a Form 483 with 3 observations to Sovereign Pharmaceuticals, LLC in Fort Worth, Texas (FEI 3003229412) after an inspection that ran Aug 17 – Aug 21, 2015. The investigators were Matthew R. Maddox, Scott Ballard and Unnee Ranjan. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Protective apparel is not worn as necessary to protect…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Buildings used in the manufacturing, processing, and packing of a drug product are not maintained in…
This inspection in context
Matthew R. Maddox
4 documents · 2015–2016
Cites 110.35 (sanitary operations) 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 211.28(a)
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 facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Sovereign Pharmaceuticals, LLC?
Matthew R. Maddox, Scott Ballard and Unnee Ranjan are named on this Form 483, for the inspection of Aug 17 – Aug 21, 2015. Each investigator has a profile showing what they cite most.
When was Sovereign Pharmaceuticals, LLC inspected by FDA?
The inspection ran Aug 17 – Aug 21, 2015, and the Form 483 is dated August 21, 2015.
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.