Kerber USA Inc
Form 483 issued November 2, 2022 · Amherst, New York
- Inspection
- Oct 31 – Nov 2, 2022
- Investigator
- Matthew D. Schnittker
- Observations
- 7
- Pages
- 5
- FEI number
- 3017419219
In short: On November 2, 2022, FDA issued a Form 483 with 7 observations to Kerber USA Inc in Amherst, New York (FEI 3017419219) after an inspection that ran Oct 31 – Nov 2, 2022. The investigator was Matthew D. Schnittker. Most observations concern cAPA and design controls.
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for corrective and preventive action…
- 04
Procedures for quality audits…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmKerber USA Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kerber USA Inc?
FDA listed 7 observations on this Form 483, mostly about cAPA, design controls and management controls. The opening words of each observation are shown on this page.
Who inspected Kerber USA Inc?
Matthew D. Schnittker is named on this Form 483, for the inspection of Oct 31 – Nov 2, 2022. Each investigator has a profile showing what they cite most.
When was Kerber USA Inc inspected by FDA?
The inspection ran Oct 31 – Nov 2, 2022, and the Form 483 is dated November 2, 2022.
How do I get the full Form 483 for Kerber 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.