Nesher Pharmaceuticals (USA) LLC
Form 483 issued July 31, 2019 · Bridgeton, Missouri
- Inspection
- Jul 29 – Jul 31, 2019
- Investigators
- Bei Y. He· Wayne D. McGrath
- Observations
- 3
- Pages
- 3
- FEI number
- 1922352
In short: On July 31, 2019, FDA issued a Form 483 with 3 observations to Nesher Pharmaceuticals (USA) LLC in Bridgeton, Missouri (FEI 1922352) after an inspection that ran Jul 29 – Jul 31, 2019. The investigators were Bei Y. He and Wayne D. McGrath. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
The written stability testing…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmNesher Pharmaceuticals (USA) LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nesher Pharmaceuticals (USA) LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Nesher Pharmaceuticals (USA) LLC?
Bei Y. He and Wayne D. McGrath are named on this Form 483, for the inspection of Jul 29 – Jul 31, 2019. Each investigator has a profile showing what they cite most.
When was Nesher Pharmaceuticals (USA) LLC inspected by FDA?
The inspection ran Jul 29 – Jul 31, 2019, and the Form 483 is dated July 31, 2019.
How do I get the full Form 483 for Nesher Pharmaceuticals (USA) 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.