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Everest Life Sciences LLC FDA Inspection Record

FEI 2243092 · Inspections, Form 483s, warning letters and import refusals

Everest Life Sciences LLC is an FDA-inspected facility (FEI 2243092) located in Plainsboro, NJ, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (4 VAI, 2 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
Form 483 and inspection documents
4 in FDA's reading room
Recalls as the recalling firm
1, latest Sep 9, 2021

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 23, 2025Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Computer control of master formula records (21 CFR 211.68(b))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
and 2 more
Oct 23, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 13, 2018No Action Indicated (NAI)No citations listed
Mar 16, 2016No Action Indicated (NAI)No citations listed
Apr 16, 2012Voluntary Action Indicated (VAI)No citations listed
Feb 18, 2011Voluntary Action Indicated (VAI)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
Sep 9, 2021Class ID-0008-2022Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only…
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold…

Form 483s and inspection documents

  • 483 Response on FDA.gov
    FDA listing date Jul 28, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    FDA listing date Jul 28, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 Response on FDA.gov
    FDA listing date Jul 11, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.
  • 483 on FDA.gov
    Inspection on Feb 18, 2011 (dates printed on the document). FDA listing date Jul 28, 2015. Published by FDA Jan 18, 2024.

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
Everest Life Sciences LLC
Location
Plainsboro, NJ (US)
Source
inspections

FDA data resources

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