US Specialty Formulations LLC
Form 483 issued August 29, 2017 · Bethlehem, Pennsylvania
- Inspection
- Aug 9 – Aug 29, 2017
- Investigator
- James M. Mason
- Observations
- 7
- Pages
- 7
- FEI number
- 3010680515
In short: On August 29, 2017, FDA issued a Form 483 with 7 observations to US Specialty Formulations LLC in Bethlehem, Pennsylvania (FEI 3010680515) after an inspection that ran Aug 9 – Aug 29, 2017. The investigator was James M. Mason. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate…
- 02
Aseptic processing areas are deficient regarding the system for cleaning an d disinfecting the room and…
- 03
Equipment and utensils are not cleaned an d maintained at appropriate intervals to prevent contamination that…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) 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 211.28(a)
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 facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected US Specialty Formulations LLC?
James M. Mason is named on this Form 483, for the inspection of Aug 9 – Aug 29, 2017. Each investigator has a profile showing what they cite most.
When was US Specialty Formulations LLC inspected by FDA?
The inspection ran Aug 9 – Aug 29, 2017, and the Form 483 is dated August 29, 2017.
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.