Nesher Pharmaceuticals (USA) LLC
Form 483 issued May 31, 2019 · Saint Louis, Missouri
- Inspection
- May 13 – May 31, 2019
- Observations
- 3
- Pages
- 4
- FEI number
- 1937079
In short: On May 31, 2019, FDA issued a Form 483 with 3 observations to Nesher Pharmaceuticals (USA) LLC in Saint Louis, Missouri (FEI 1937079) after an inspection that ran May 13 – May 31, 2019. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Production personnel were not practicing good…
This inspection in context
Questions about this 483
What did FDA find at Nesher Pharmaceuticals (USA) LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
When was Nesher Pharmaceuticals (USA) LLC inspected by FDA?
The inspection ran May 13 – 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.