Nomax, INC
Form 483 issued February 1, 2018 · Saint Louis, Missouri
- Inspection
- Jan 23 – Feb 1, 2018
- Investigator
- Robert J. Ham
- Observations
- 2
- Pages
- 3
- FEI number
- 1937310
In short: On February 1, 2018, FDA issued a Form 483 with 2 observations to Nomax, INC in Saint Louis, Missouri (FEI 1937310) after an inspection that ran Jan 23 – Feb 1, 2018. The investigator was Robert J. Ham. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmNomax, INC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nomax, INC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Nomax, INC?
Robert J. Ham is named on this Form 483, for the inspection of Jan 23 – Feb 1, 2018. Each investigator has a profile showing what they cite most.
When was Nomax, INC inspected by FDA?
The inspection ran Jan 23 – Feb 1, 2018, and the Form 483 is dated February 1, 2018.
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.