Nortech Laboratories
Form 483 issued March 13, 2015 · Farmingdale, New York
- Inspection
- Mar 4 – Mar 13, 2015
- Investigator
- Meredith P. Soehl
- Observations
- 5
- Pages
- 3
- FEI number
- 2415591
In short: On March 13, 2015, FDA issued a Form 483 with 5 observations to Nortech Laboratories in Farmingdale, New York (FEI 2415591) after an inspection that ran Mar 4 – Mar 13, 2015. The investigator was Meredith P. Soehl. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
- 02
Process validation activities have not been…
- 03
Records for complaints where no investigation was made do…
- 04
Products that do not conform to specifications…
This inspection in context
Meredith P. Soehl
4 documents · 2009–2019
Cites 110.80(a)(4) (processes and controls) more than any other section. Most of their documents are for sites in New York.
The firmNortech Laboratories history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nortech Laboratories?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Nortech Laboratories?
Meredith P. Soehl is named on this Form 483, for the inspection of Mar 4 – Mar 13, 2015. Each investigator has a profile showing what they cite most.
When was Nortech Laboratories inspected by FDA?
The inspection ran Mar 4 – Mar 13, 2015, and the Form 483 is dated March 13, 2015.
How do I get the full Form 483 for Nortech Laboratories?
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.