Shire Human Genetic Therapies, Inc. FDA Record
Shire Human Genetic Therapies, Inc. has 5 FDA recalls (5 Class I), 32 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Shire Human Genetic Therapies, Inc." is on file.
- Latest recall
- D-0036-2020 · Class I · Sep 12, 2019
- Latest inspection
- Dec 18, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 (5 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 32 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 4 | 4 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0036-2020 | Class I | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For… | Sep 12, 2019 |
| D-0038-2020 | Class I | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For… | Sep 12, 2019 |
| D-0035-2020 | Class I | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For… | Sep 12, 2019 |
| D-0037-2020 | Class I | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For… | Sep 12, 2019 |
| D-1251-2014 | Class I | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human… | Mar 14, 2014 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 18, 2025 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Sep 12, 2025 | Cambridge, MA | Drugs | Voluntary Action Indicated (VAI) | 3005955297 |
| Apr 22, 2022 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Jan 15, 2020 | Lexington, MA | Drugs | No Action Indicated (NAI) | 3009340644 |
| Jul 25, 2018 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Feb 1, 2018 | Cambridge, MA | Drugs | Voluntary Action Indicated (VAI) | 3005955297 |
| Jan 20, 2017 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Jan 5, 2017 | North Reading, MA | Drugs | No Action Indicated (NAI) | 3008424653 |
| Jul 28, 2016 | Lexington, MA | Drugs | No Action Indicated (NAI) | 3009340644 |
| Sep 4, 2015 | Cambridge, MA | Drugs | No Action Indicated (NAI) | 3005955297 |
| Aug 14, 2015 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Jul 15, 2015 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Aug 6, 2014 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Jan 30, 2014 | North Reading, MA | Drugs | Voluntary Action Indicated (VAI) | 3008424653 |
| Aug 5, 2013 | Cambridge, MA | Drugs | Voluntary Action Indicated (VAI) | 3005955297 |
| May 23, 2013 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Aug 31, 2012 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Apr 2, 2012 | Lexington, MA | Drugs | No Action Indicated (NAI) | 3009340644 |
| Feb 1, 2012 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
| Jan 11, 2012 | Lexington, MA | Drugs | Voluntary Action Indicated (VAI) | 3009340644 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3009340644 | Lexington, MA | 20 | Dec 18, 2025 |
| FEI 3005955297 | Cambridge, MA | 8 | Sep 12, 2025 |
| FEI 3008424653 | North Reading, MA | 4 | Jan 5, 2017 |
Shire Human Genetic Therapies, Inc. and the FDA: common questions
Has Shire Human Genetic Therapies, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Shire Human Genetic Therapies, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Shire Human Genetic Therapies, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Shire Human Genetic Therapies, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shire Human Genetic Therapies, Inc.?
The most recent FDA inspection on file ended Dec 18, 2025 at Lexington, MA and was classified VAI. FDA has 32 inspections of Shire Human Genetic Therapies, Inc. on file.
Has Shire Human Genetic Therapies, Inc. had an FDA recall?
Yes. Shire Human Genetic Therapies, Inc. has 5 FDA recalls on record, 5 of them Class I, the most serious class. The most recent started Sep 12, 2019.
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