Medical Components, Inc dba MedComp
Form 483 issued February 12, 2015 · Harleysville, Pennsylvania
- Inspection
- Jan 13 – Feb 12, 2015
- Investigator
- Michael J. Nerz
- Observations
- 12
- Pages
- 7
- FEI number
- 2518902
In short: On February 12, 2015, FDA issued a Form 483 with 12 observations to Medical Components, Inc dba MedComp in Harleysville, Pennsylvania (FEI 2518902) after an inspection that ran Jan 13 – Feb 12, 2015. The investigator was Michael J. Nerz. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
CAPA and production & process controls account for 8 of 12 observations.
Most cited: 21 CFR 820.50 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Corrective and preventive action activities and/or results have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Written MDR procedures have…
- 04
A correction or removal, conducted to reduce a risk to health posed by a device, was…
This inspection in context
Michael J. Nerz
1 document · 2015
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMedical Components, Inc dba MedComp history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical Components, Inc dba MedComp?
FDA listed 12 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Medical Components, Inc dba MedComp?
Michael J. Nerz is named on this Form 483, for the inspection of Jan 13 – Feb 12, 2015. Each investigator has a profile showing what they cite most.
When was Medical Components, Inc dba MedComp inspected by FDA?
The inspection ran Jan 13 – Feb 12, 2015, and the Form 483 is dated February 12, 2015.
How do I get the full Form 483 for Medical Components, Inc dba MedComp?
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.