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Nostrum Laboratories, Inc. FDA Inspection Record

FEI 1518957 · Inspections, Form 483s, warning letters and import refusals

Nostrum Laboratories, Inc. is an FDA-inspected facility (FEI 1518957) located in Bryan, OH, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 13, 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
Recalls as the recalling firm
2, latest Jul 11, 2025
Import refusals
1

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 13, 2025Voluntary Action Indicated (VAI)Valid stability test methods (21 CFR 211.166(a)(3))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Jan 11, 2018No Action Indicated (NAI)No citations listed
Mar 15, 2016No Action Indicated (NAI)No citations listed
Jun 28, 2013Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Written procedures not established/followed (21 CFR 211.67(b))
Equipment for Environmental Control (21 CFR 211.46(b))
Establishment of calibration procedures (21 CFR 211.160(b)(4))
Jul 21, 2011Voluntary Action Indicated (VAI)No citations listed
Jul 16, 2010Voluntary 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
Jul 11, 2025Class IID-0547-2025Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b)…
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence…
May 23, 2016Class IID-1030-2016Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT…
Failed Dissolution Specifications

FDA record score

10 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
Inspection classified VAIMar 13, 20256 x 16
Class II recall D-0547-2025, this FEI as the recalling firmJul 11, 20254 x 14
Class II recall D-1030-2016, this FEI as the recalling firmMay 23, 201610 years or older, so it adds no points0
Inspection classified VAIJun 28, 201310 years or older, so it adds no points0
Inspection classified VAIJul 21, 201110 years or older, so it adds no points0
Inspection classified VAIJul 16, 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
Nostrum Laboratories, Inc.
Location
Bryan, OH (US)
Source
inspections

Import refusals

FDA data resources

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