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David S. Krakow, M.D. — FDA Facility Profile

FEI 3039842677

David S. Krakow, M.D. is an FDA-inspected facility (FEI 3039842677) located in Mount Kisco, NY, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Nov 21, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 21, 2025Voluntary Action Indicated (VAI)Consent form not approved/signed/dated (21 CFR 50.27(a))
FD-1572, protocol compliance (21 CFR 312.60)
Informed consent (21 CFR 312.60)

Facility details

Company
David S. Krakow, M.D.
Location
Mount Kisco, NY (US)
Source
inspections

FDA data resources

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