CooperSurgical, Inc.
Form 483 issued February 1, 2024 · North Tonawanda, New York
- Inspection
- Jan 29 – Feb 1, 2024
- Investigator
- Matthew D. Schnittker
- Observations
- 2
- Pages
- 4
- FEI number
- 1316626
In short: On February 1, 2024, FDA issued a Form 483 with 2 observations to CooperSurgical, Inc. in North Tonawanda, New York (FEI 1316626) after an inspection that ran Jan 29 – Feb 1, 2024. The investigator was Matthew D. Schnittker. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.100 (1×) · 820.75 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Manufacturer A process whose results cannot be fully verified by subsequent inspection and test has not…
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 firmCooperSurgical, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CooperSurgical, Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. 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 CooperSurgical, Inc.?
Matthew D. Schnittker is named on this Form 483, for the inspection of Jan 29 – Feb 1, 2024. Each investigator has a profile showing what they cite most.
When was CooperSurgical, Inc. inspected by FDA?
The inspection ran Jan 29 – Feb 1, 2024, and the Form 483 is dated February 1, 2024.
How do I get the full Form 483 for CooperSurgical, 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.