Pinnacle Fertility Labs New York FDA Record

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

  • Latest inspection VAI · Dec 14, 2023
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Pinnacle Fertility Labs New York has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pinnacle Fertility Labs New York" is on file.

What these totals cover: FDA records filed under the name "Pinnacle Fertility Labs New York".

Latest inspection
Dec 14, 2023 · VAI

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
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Dec 14, 2023.

DateSiteProductClassificationFEI
Dec 14, 2023New York, NYBiologicsVoluntary Action Indicated (VAI)3027263707
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3027263707New York, NY1Dec 14, 2023

Pinnacle Fertility Labs New York and the FDA: common questions

Has Pinnacle Fertility Labs New York received an FDA warning letter?

No FDA warning letter addressed to the name "Pinnacle Fertility Labs New York" 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 Pinnacle Fertility Labs New York received an FDA Form 483?

FDA has not published a Form 483 for "Pinnacle Fertility Labs New York" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Pinnacle Fertility Labs New York?

The most recent FDA inspection on file ended Dec 14, 2023 at New York, NY and was classified VAI. FDA has 1 inspection of Pinnacle Fertility Labs New York on file.

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