Sovereign Pharmaceuticals, LLC
Form 483 issued January 12, 2018 · Fort Worth, Texas
- Inspection
- Jan 8 – Jan 12, 2018
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 2
- Pages
- 3
- FEI number
- 3003229412
In short: On January 12, 2018, FDA issued a Form 483 with 2 observations to Sovereign Pharmaceuticals, LLC in Fort Worth, Texas (FEI 3003229412) after an inspection that ran Jan 8 – Jan 12, 2018. The investigator was Patty P. Kaewussdangkul. Most observations concern laboratory controls and materials.
At a glance
Laboratory controls and materials account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability testing…
- 02
Written procedures are not followed for…
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sovereign Pharmaceuticals, LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and materials. 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 Jan 8 – Jan 12, 2018. Each investigator has a profile showing what they cite most.
When was Sovereign Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 8 – Jan 12, 2018, and the Form 483 is dated January 12, 2018.
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.