Nomax, INC
Form 483 issued December 2, 2022 · Saint Louis, Missouri
- Observations
- 3
- Pages
- 5
- FEI number
- 1937310
In short: On December 2, 2022, FDA issued a Form 483 with 3 observations to Nomax, INC in Saint Louis, Missouri (FEI 1937310). Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Nomax, INC?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Nomax, INC inspected by FDA?
This Form 483 is dated December 2, 2022.
How do I get the full Form 483 for Nomax, INC?
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.