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Allegiant Health FDA Inspection Record

FEI 3001195380 · Inspections, Form 483s, warning letters and import refusals

Allegiant Health is an FDA-registered facility (FEI 3001195380) located in Deer Park, NY, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; REPACK. RegDataLab tracks 12 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 11, 2025: No Action Indicated (NAI)
Inspections on record
12 (7 VAI, 5 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
5, latest Oct 21, 2024

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

Showing the 10 most recent of 12 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 11, 2025No Action Indicated (NAI)No citations listed
Apr 24, 2024No Action Indicated (NAI)No citations listed
Jun 13, 2019No Action Indicated (NAI)No citations listed
Nov 2, 2016Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Following/documenting laboratory controls (21 CFR 211.160(a))
Sewage and refuse disposal in safe manner (21 CFR 211.50)
Reserve samples identified, representative, stored (21 CFR 211.170(b))
and 2 more
Jun 2, 2015Voluntary Action Indicated (VAI)Approve or reject procedures or specs (21 CFR 211.22(c))
Procedures not in writing, fully followed (21 CFR 211.22(d))
Training--operations, GMPs, written procedures (21 CFR 211.25(a))
In-Process Material Area (21 CFR 211.42(c)(4))
and 5 more
May 7, 2014Voluntary Action Indicated (VAI)Adequate lab facilities not available (21 CFR 211.22(b))
Procedures not in writing, fully followed (21 CFR 211.22(d))
GMP Training Frequency (21 CFR 211.25(a))
Equipment Design, Size and Location (21 CFR 211.63)
and 13 more
May 16, 2013Voluntary Action Indicated (VAI)Labels and labeling stored separately (21 CFR 211.122(d))
Strict control not exercised over labeling issued (21 CFR 211.125(a))
Procedures Written and Followed (21 CFR 211.125(f))
Procedures are written, and followed (21 CFR 211.130)
and 8 more
Nov 15, 2011Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
May 13, 2011Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Written calibration / inspection records not kept (21 CFR 211.68(a))
Representative Samples (21 CFR 211.84(b))
and 4 more
May 25, 2010Voluntary Action Indicated (VAI)Approve or reject procedures or specs (21 CFR 211.22(c))
Cleaning SOPs/instructions (21 CFR 211.67(b)(3))
SOPs not followed / documented (21 CFR 211.100(b))
Equipment for Environmental Control (21 CFR 211.46(b))
and 1 more

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 21, 2024Class IID-0029-2025Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs…
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Feb 16, 2017Class IID-0500-2017HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged…
cGMP deviations - presence of rubber particles found loose in the bulk product.
Feb 29, 2016Class IIID-0856-2016col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item…
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
May 12, 2015Class IID-1134-2015Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a)…
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Mar 7, 2008Class IIID-186-2008Children's Chewable Aspirin, 81 mg each, Pain Reliever/Fever Reducer, ORANGE FLAVOR, 36… and 2 more products
Failure to validate manufacturing process; the products were re-worked without proper validation.

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
BLI International, Inc.
Location
Deer Park, NY (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; REPACK
Source
decrs

FDA data resources

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