Cosmax USA, Inc
Form 483 issued March 17, 2020 · Solon, Ohio
- Inspection
- Feb 24 – Mar 17, 2020
- Investigator
- Jazmine N. Still
- Observations
- 1
- Pages
- 6
- FEI number
- 1527228
In short: On March 17, 2020, FDA issued a Form 483 with 1 observation to Cosmax USA, Inc in Solon, Ohio (FEI 1527228) after an inspection that ran Feb 24 – Mar 17, 2020. The investigator was Jazmine N. Still. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (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…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmCosmax USA, Inc history
All 2 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 Cosmax USA, Inc?
FDA listed 1 observation 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 Cosmax USA, Inc?
Jazmine N. Still is named on this Form 483, for the inspection of Feb 24 – Mar 17, 2020. Each investigator has a profile showing what they cite most.
When was Cosmax USA, Inc inspected by FDA?
The inspection ran Feb 24 – Mar 17, 2020, and the Form 483 is dated March 17, 2020.
How do I get the full Form 483 for Cosmax USA, 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.