US Specialty Formulations LLC
Form 483 issued May 29, 2015 · Bethlehem, Pennsylvania
- Inspection
- May 11 – May 29, 2015
- Investigators
- Anita R. Michael· James M. Mason
- Observations
- 12
- Pages
- 8
- FEI number
- 3010680515
In short: On May 29, 2015, FDA issued a Form 483 with 12 observations to US Specialty Formulations LLC in Bethlehem, Pennsylvania (FEI 3010680515) after an inspection that ran May 11 – May 29, 2015. The investigators were Anita R. Michael and James M. Mason. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 8 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) 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 211.113(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 12 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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?
Anita R. Michael and James M. Mason are named on this Form 483, for the inspection of May 11 – May 29, 2015. Each investigator has a profile showing what they cite most.
When was US Specialty Formulations LLC inspected by FDA?
The inspection ran May 11 – May 29, 2015, and the Form 483 is dated May 29, 2015.
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.