CNY Fertility, PLLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

CNY Fertility, PLLC has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CNY Fertility, PLLC" is on file.

What these totals cover: FDA records filed under the name "CNY Fertility, PLLC" and its spelling variant "Cny Fertility Pllc".

Latest inspection
Apr 22, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

CNY Fertility, PLLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

CNY Fertility, PLLC: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 2 inspections220222023: 0 inspections020232024: 2 inspections220242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202420000
202300000
202220000
202100000
202010000
201900000
201800000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

10 inspections from Apr 16, 2009 to Apr 22, 2025.

DateSiteProductClassificationFEI
Apr 22, 2025Sarasota, FLBiologicsNo Action Indicated (NAI)3026925642
Jun 13, 2024Latham, NYBiologicsNo Action Indicated (NAI)3005841676
May 28, 2024Williamsville, NYBiologicsNo Action Indicated (NAI)3017876311
May 26, 2022Williamsville, NYBiologicsNo Action Indicated (NAI)3017876311
Mar 17, 2022Latham, NYBiologicsNo Action Indicated (NAI)3005841676
Jan 24, 2020Latham, NYBiologicsNo Action Indicated (NAI)3005841676
Jun 13, 2017Latham, NYBiologicsNo Action Indicated (NAI)3005841676
Mar 31, 2015Latham, NYBiologicsVoluntary Action Indicated (VAI)3005841676
Nov 23, 2011Latham, NYBiologicsNo Action Indicated (NAI)3005841676
Apr 16, 2009Latham, NYBiologicsNo Action Indicated (NAI)3005841676
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3026925642Sarasota, FL1Apr 22, 2025
FEI 3005841676Latham, NY7Jun 13, 2024
FEI 3017876311Williamsville, NY2May 28, 2024

CNY Fertility, PLLC and the FDA: common questions

Has CNY Fertility, PLLC received an FDA warning letter?

No FDA warning letter addressed to the name "CNY Fertility, PLLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has CNY Fertility, PLLC received an FDA Form 483?

FDA has not published a Form 483 for "CNY Fertility, PLLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect CNY Fertility, PLLC?

The most recent FDA inspection on file ended Apr 22, 2025 at Sarasota, FL and was classified NAI. FDA has 10 inspections of CNY Fertility, PLLC on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.