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ZOLL Palm Springs FDA Inspection Record

FEI 2021710 · Inspections, Form 483s, warning letters and import refusals

ZOLL Palm Springs is an FDA-registered facility (FEI 2021710) located in Palm Springs, CA, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 8, 2022: No Action Indicated (NAI)
Inspections on record
4 (4 NAI)
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
Recalls as the recalling firm
1, latest Oct 17, 2005
Import refusals
9

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
Apr 8, 2022No Action Indicated (NAI)No citations listed
May 5, 2017No Action Indicated (NAI)No citations listed
Oct 31, 2014No Action Indicated (NAI)Quality assurance procedures: 6-month & annual audits (21 CFR 821.25(c)(3))
Report of Death or Serious Injury (21 CFR 803.50(a)(1))
Death (21 CFR 803.52(b)(2))
Device Identification Information (21 CFR 803.52(c)(4))
Aug 22, 2011No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 17, 2005Class IID-021-6microNEFRIN (racemic epinephrine) Each 100 mL contains racemic methylamino-ethanol…
Lack of Assurance of Sterility; product not manufactured sterile as required by the FDA Sterility Requirement for Aqueous-Based Drug…

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

1 record behind this number
RecordDatePoints x age weightAdds
Class II recall D-021-6, this FEI as the recalling firmOct 17, 200510 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Vyaire Medical, Inc.
Location
Palm Springs, CA (US)
Source
device

Import refusals

FDA data resources

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