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GC Hanford Manufacturing Company FDA Inspection Record

FEI 1310197 · Inspections, Form 483s, warning letters and import refusals

GC Hanford Manufacturing Company is an FDA-inspected facility (FEI 1310197) located in Syracuse, NY, US. RegDataLab tracks 19 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 20, 2025: Voluntary Action Indicated (VAI)
Inspections on record
19 (12 VAI, 7 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 Feb 24, 2006

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 19 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 20, 2025Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Floors, walls, ceiling surfaces (21 CFR 211.42(c)(10)(i))
and 2 more
Jun 17, 2022Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Equipment Design, Size and Location (21 CFR 211.63)
Control procedures to monitor and validate performance (21 CFR 211.110(a))
Sep 27, 2019Voluntary Action Indicated (VAI)Cleaning SOPs/instructions (21 CFR 211.67(b)(3))
Written warehousing procedures established/followed (21 CFR 211.142)
Sep 27, 2019Voluntary Action Indicated (VAI)Cleaning SOPs/instructions (21 CFR 211.67(b)(3))
Rejecting When Specifications Not Met (21 CFR 211.84(e))
Written warehousing procedures established/followed (21 CFR 211.142)
Dec 16, 2016Voluntary Action Indicated (VAI)Computer control of master formula records (21 CFR 211.68(b))
Quarantined Drug Products Area (21 CFR 211.42(c)(7))
Following/documenting laboratory controls (21 CFR 211.160(a))
Calibration - at intervals, written program, remedial action (21 CFR 211.160(b)(4))
and 2 more
Dec 14, 2016No Action Indicated (NAI)No citations listed
Aug 11, 2016No Action Indicated (NAI)No citations listed
Jul 7, 2015No Action Indicated (NAI)No citations listed
Apr 23, 2015Voluntary Action Indicated (VAI)Prepared for each batch, include complete information (21 CFR 211.188)
Written sanitation procedures not followed (21 CFR 211.56(b))
Nov 30, 2012Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))

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
Feb 24, 2006Class ID-218-6Cefazolin for Injection, USP, 1 g/10 mL vials, single use vials, 25 single use vials per…
NON STERILITY: Finished product lots lack sterility assurance because certain lots of the bulk API were found to have microbial…

FDA record score

11 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.

13 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 20, 20256 x 16
Inspection classified VAIJun 17, 20226 x 0.63.6
Inspection classified VAISep 27, 20196 x 0.251.5
Inspection classified VAISep 27, 2019Only the 3 most recent VAI inspections add points0
Inspection classified VAIDec 16, 2016Only the 3 most recent VAI inspections add points0
Inspection classified VAIApr 23, 201510 years or older, so it adds no points0
Inspection classified VAINov 30, 201210 years or older, so it adds no points0
Inspection classified VAIMar 9, 201210 years or older, so it adds no points0
Inspection classified VAIMar 4, 201110 years or older, so it adds no points0
Inspection classified VAIJun 14, 201010 years or older, so it adds no points0
Inspection classified VAIMar 12, 201010 years or older, so it adds no points0
Inspection classified VAIFeb 10, 201010 years or older, so it adds no points0
Class I recall D-218-6, this FEI as the recalling firmFeb 24, 200610 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
GC Hanford Manufacturing Company
Location
Syracuse, NY (US)
Source
inspections

FDA data resources

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