Marlen Manufacturing & Development Co.
Form 483 issued March 13, 2017 · Bedford, Ohio
- Inspection
- Mar 2 – Mar 13, 2017
- Investigator
- Laureen M. Geniusz
- Observations
- 1
- Pages
- 4
- FEI number
- 1520020
In short: On March 13, 2017, FDA issued a Form 483 with 1 observation to Marlen Manufacturing & Development Co. in Bedford, Ohio (FEI 1520020) after an inspection that ran Mar 2 – Mar 13, 2017. The investigator was Laureen M. Geniusz. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
This inspection in context
Laureen M. Geniusz
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Ohio.
The firmMarlen Manufacturing & Development Co. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Marlen Manufacturing & Development Co.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Marlen Manufacturing & Development Co.?
Laureen M. Geniusz is named on this Form 483, for the inspection of Mar 2 – Mar 13, 2017. Each investigator has a profile showing what they cite most.
When was Marlen Manufacturing & Development Co. inspected by FDA?
The inspection ran Mar 2 – Mar 13, 2017, and the Form 483 is dated March 13, 2017.
How do I get the full Form 483 for Marlen Manufacturing & Development Co.?
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.