US Specialty Formulations LLC
Form 483 issued January 14, 2026 · Allentown, Pennsylvania
- Inspection
- Jan 5 – Jan 14, 2026
- Investigators
- Lu Chen· Mindy M. Chou
- Observations
- 7
- Pages
- 7
- FEI number
- 3010680515
In short: On January 14, 2026, FDA issued a Form 483 with 7 observations to US Specialty Formulations LLC in Allentown, Pennsylvania (FEI 3010680515) after an inspection that ran Jan 5 – Jan 14, 2026. The investigators were Lu Chen and Mindy M. Chou. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and materials account for 5 of 7 observations.
Most cited: 21 CFR 211.165 (2×)
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
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
There is no written testing program designed to assess the stability…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Lu Chen
4 documents · 2024–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.165
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, materials and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected US Specialty Formulations LLC?
Lu Chen and Mindy M. Chou are named on this Form 483, for the inspection of Jan 5 – Jan 14, 2026. Each investigator has a profile showing what they cite most.
When was US Specialty Formulations LLC inspected by FDA?
The inspection ran Jan 5 – Jan 14, 2026, and the Form 483 is dated January 14, 2026.
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.