US Specialty Formulations LLC
Form 483 issued July 2, 2024 · Allentown, Pennsylvania
- Inspection
- Jun 17 – Jul 2, 2024
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 7
- Pages
- 6
- FEI number
- 3010680515
In short: On July 2, 2024, FDA issued a Form 483 with 7 observations to US Specialty Formulations LLC in Allentown, Pennsylvania (FEI 3010680515) after an inspection that ran Jun 17 – Jul 2, 2024. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, drng…
- 02
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of…
- 03
The written stability program for drug products does not include reliable, meaningful…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmUS Specialty Formulations LLC history
All 10 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 US Specialty Formulations LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected US Specialty Formulations LLC?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Jun 17 – Jul 2, 2024. Each investigator has a profile showing what they cite most.
When was US Specialty Formulations LLC inspected by FDA?
The inspection ran Jun 17 – Jul 2, 2024, and the Form 483 is dated July 2, 2024.
How do I get the full Form 483 for US Specialty Formulations 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.