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Amryt Pharmaceuticals, Inc.

FDA Regulatory Profile

Amryt Pharmaceuticals, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Amryt Pharmaceuticals, Inc." and its spelling variant "Amryt Pharmaceuticals".

Latest inspection: Sep 14, 2022 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Amryt Pharmaceuticals, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	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	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

4 inspections from Aug 27, 2012 to Sep 14, 2022.

Date	Site	Product	Classification	FEI
Sep 14, 2022	Boston, MA	Drugs	No Action Indicated (NAI)	3009569098
Jan 23, 2020	Boston, MA	Drugs	No Action Indicated (NAI)	3009569098
Jul 16, 2015	Boston, MA	Drugs	Voluntary Action Indicated (VAI)	3009569098
Aug 27, 2012	Boston, MA	Drugs	No Action Indicated (NAI)	3009569098

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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Amryt Pharmaceuticals, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 8, 2013.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3009569098	Boston, MA	4	Sep 14, 2022

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