Nesher Pharmaceuticals (USA) LLC
Form 483 issued May 31, 2019 · Bridgeton, Missouri
- Inspection
- May 3 – May 31, 2019
- Investigators
- Ana P. Sandee· William Fred Lagud Jr
- Observations
- 8
- Pages
- 10
- FEI number
- 1922352
In short: On May 31, 2019, FDA issued a Form 483 with 8 observations to Nesher Pharmaceuticals (USA) LLC in Bridgeton, Missouri (FEI 1922352) after an inspection that ran May 3 – May 31, 2019. The investigators were Ana P. Sandee and William Fred Lagud Jr. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The specificity and reproducibility of test methods have not…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Adverse drug experiences that were the subject of post marketing 15-day reports…
This inspection in context
Ana P. Sandee
6 documents · 2019–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
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 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Nesher Pharmaceuticals (USA) LLC?
Ana P. Sandee and William Fred Lagud Jr are named on this Form 483, for the inspection of May 3 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Nesher Pharmaceuticals (USA) LLC inspected by FDA?
The inspection ran May 3 – May 31, 2019, and the Form 483 is dated May 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.