Nesher Pharmaceuticals (USA) LLC
Form 483 issued August 12, 2021 · Bridgeton, Missouri
- Investigators
- Alan M. Barker· Robert J. Ham
- Observations
- 2
- Pages
- 3
- FEI number
- 1922352
In short: On August 12, 2021, FDA issued a Form 483 with 2 observations to Nesher Pharmaceuticals (USA) LLC in Bridgeton, Missouri (FEI 1922352). The investigators were Alan M. Barker and Robert J. Ham. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nesher Pharmaceuticals (USA) LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Nesher Pharmaceuticals (USA) LLC?
Alan M. Barker and Robert J. Ham are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Nesher Pharmaceuticals (USA) LLC inspected by FDA?
This Form 483 is dated August 12, 2021.
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.