Modern Products, Inc
Form 483 issued May 13, 2015 · Mequon, Wisconsin
- Inspection
- May 5 – May 13, 2015
- Investigator
- Denise L. Burosh
- Observations
- 12
- Pages
- 4
- FEI number
- 2120711
In short: On May 13, 2015, FDA issued a Form 483 with 12 observations to Modern Products, Inc in Mequon, Wisconsin (FEI 2120711) after an inspection that ran May 5 – May 13, 2015. The investigator was Denise L. Burosh. Most observations concern quality system and production.
At a glance
Quality system and production account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
The in process control procedures were deficient in that they did not include an examination ofthe…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials…
This inspection in context
Denise L. Burosh
1 document · 2015
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Wisconsin.
The firmModern Products, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Modern Products, Inc?
FDA listed 12 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected Modern Products, Inc?
Denise L. Burosh is named on this Form 483, for the inspection of May 5 – May 13, 2015. Each investigator has a profile showing what they cite most.
When was Modern Products, Inc inspected by FDA?
The inspection ran May 5 – May 13, 2015, and the Form 483 is dated May 13, 2015.
How do I get the full Form 483 for Modern Products, 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.