US Specialty Formulations LLC
Form 483 issued July 23, 2019 · Bethlehem, Pennsylvania
- Inspection
- Jun 18 – Jul 23, 2019
- Investigators
- Craig D. Zagata· John M. Mastalski
- Observations
- 11
- Pages
- 5
- FEI number
- 3010680515
In short: On July 23, 2019, FDA issued a Form 483 with 11 observations to US Specialty Formulations LLC in Bethlehem, Pennsylvania (FEI 3010680515) after an inspection that ran Jun 18 – Jul 23, 2019. The investigators were Craig D. Zagata and John M. Mastalski. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 8 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Drug products failing to meet established…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) 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 211.100(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 11 observations on this Form 483, mostly about laboratory controls, production 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?
Craig D. Zagata and John M. Mastalski are named on this Form 483, for the inspection of Jun 18 – Jul 23, 2019. Each investigator has a profile showing what they cite most.
When was US Specialty Formulations LLC inspected by FDA?
The inspection ran Jun 18 – Jul 23, 2019, and the Form 483 is dated July 23, 2019.
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.