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NuCare Pharmaceuticals,Inc. FDA Inspection Record

FEI 3003294404 · Inspections, Form 483s, warning letters and import refusals

NuCare Pharmaceuticals,Inc. is an FDA-registered facility (FEI 3003294404) located in ORANGE, CA, US. Registered operations: MANUFACTURE; RELABEL; REPACK. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Mar 12, 2025: No Action Indicated (NAI)
Inspections on record
7 (4 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Sep 27, 2019
Recalls as the recalling firm
2, latest Jul 30, 2018

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
Mar 12, 2025No Action Indicated (NAI)No citations listed
Jan 10, 2020Voluntary Action Indicated (VAI)Expiration date lacking (21 CFR 211.137(a))
Sep 19, 2018No Action Indicated (NAI)No citations listed
Mar 21, 2018Voluntary Action Indicated (VAI)Scientifically sound laboratory controls (21 CFR 211.160(b))
Feb 13, 2015Voluntary Action Indicated (VAI)No citations listed
Mar 31, 2011No Action Indicated (NAI)No citations listed
Jun 14, 2010Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Unlabeled filled containers controls (21 CFR 211.130(b))
Calibration - at intervals, written program, remedial action (21 CFR 211.160(b)(4))
Returned drug products with doubt cast as to safety et. al. (21 CFR 211.204)

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
Jul 30, 2018Class IID-1037-2018Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare… and 2 more products
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jun 12, 2003Class IIID-275-3Lisinopril Tablets Usp, 10 mg, 10 tablet bottles, Sample Not To Be Sold, Mfr for…
Mislabeling; product label does not contain Rx only legend

FDA record score

12 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 14, 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.

6 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsSep 27, 201930 x 0.257.5
Inspection classified VAIJan 10, 20206 x 0.251.5
Inspection classified VAIMar 21, 20186 x 0.251.5
Class II recall D-1037-2018, this FEI as the recalling firmJul 30, 20184 x 0.251
Inspection classified VAIFeb 13, 201510 years or older, so it adds no points0
Inspection classified VAIJun 14, 201010 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
NuCare Pharmaceuticals Inc
Location
ORANGE, CA (US)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE; RELABEL; REPACK
Source
decrs

Compliance actions

FDA data resources

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