US Specialty Formulations LLC
Form 483 issued April 26, 2022 · Allentown, Pennsylvania
- Inspection
- Mar 21 – Apr 26, 2022
- Investigators
- Edmund F. Mrak· John R. Tuohig· Lori M. Newman
- Observations
- 17
- Pages
- 17
- FEI number
- 3010680515
In short: On April 26, 2022, FDA issued a Form 483 with 17 observations to US Specialty Formulations LLC in Allentown, Pennsylvania (FEI 3010680515) after an inspection that ran Mar 21 – Apr 26, 2022. The investigators were Edmund F. Mrak, John R. Tuohig and Lori M. Newman. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high -efficiency paiiiculate air…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at US Specialty Formulations LLC?
FDA listed 17 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected US Specialty Formulations LLC?
Edmund F. Mrak, John R. Tuohig and Lori M. Newman are named on this Form 483, for the inspection of Mar 21 – Apr 26, 2022. Each investigator has a profile showing what they cite most.
When was US Specialty Formulations LLC inspected by FDA?
The inspection ran Mar 21 – Apr 26, 2022, and the Form 483 is dated April 26, 2022.
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.