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Shire Human Genetic Therapies, Inc. FDA Inspection Record

FEI 3009340644 · Inspections, Form 483s, warning letters and import refusals

Shire Human Genetic Therapies, Inc. is an FDA-registered facility (FEI 3009340644) located in Lexington, MA, US. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 20 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 18, 2025: Voluntary Action Indicated (VAI)
Inspections on record
20 (14 VAI, 6 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
3, latest Sep 12, 2019
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

Showing the 10 most recent of 20 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Dec 18, 2025Voluntary Action Indicated (VAI)No citations listed
Apr 22, 2022Voluntary Action Indicated (VAI)No citations listed
Jan 15, 2020No Action Indicated (NAI)No citations listed
Jul 25, 2018Voluntary Action Indicated (VAI)No citations listed
Jan 20, 2017Voluntary Action Indicated (VAI)No citations listed
Jul 28, 2016No Action Indicated (NAI)No citations listed
Aug 14, 2015Voluntary Action Indicated (VAI)No citations listed
Jul 15, 2015Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Training--operations, GMPs, written procedures (21 CFR 211.25(a))
Aug 6, 2014Voluntary Action Indicated (VAI)Late submission of 15-day report (21 CFR 314.80(c)(1)(i))
May 23, 2013Voluntary 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 12, 2019Class ID-0035-2020Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For… and 3 more products
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Mar 17, 2017Class IID-0625-2017Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp…
Presence of Particulate Matter: Glass
Mar 14, 2014Class ID-1251-2014VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only…
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.

FDA record score

16 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.

17 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIDec 18, 20256 x 16
Class I recall D-0035-2020, this FEI as the recalling firmSep 12, 201915 x 0.253.8
Inspection classified VAIApr 22, 20226 x 0.63.6
Inspection classified VAIJul 25, 20186 x 0.251.5
Class II recall D-0625-2017, this FEI as the recalling firmMar 17, 20174 x 0.251
Inspection classified VAIJan 20, 2017Only the 3 most recent VAI inspections add points0
Inspection classified VAIAug 14, 201510 years or older, so it adds no points0
Inspection classified VAIJul 15, 201510 years or older, so it adds no points0
Inspection classified VAIAug 6, 201410 years or older, so it adds no points0
Class I recall D-1251-2014, this FEI as the recalling firmMar 14, 201410 years or older, so it adds no points0
Inspection classified VAIMay 23, 201310 years or older, so it adds no points0
Inspection classified VAIAug 31, 201210 years or older, so it adds no points0
Inspection classified VAIFeb 1, 201210 years or older, so it adds no points0
Inspection classified VAIJan 11, 201210 years or older, so it adds no points0
Inspection classified VAIJul 8, 201110 years or older, so it adds no points0
Inspection classified VAIJan 7, 201010 years or older, so it adds no points0
Inspection classified VAINov 20, 200910 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
Shire Human Genetic Therapies, Inc.
Location
Lexington, MA (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
both

Import refusals

FDA data resources

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