FDA Inspection 1234317 - Abiomed, Inc. - August 05, 2025

FDA Inspection 1234317 for Abiomed, Inc. on August 05, 2025. Classification: OAI.

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Record Summary

FDA Inspection 1234317 for Abiomed, Inc. on August 05, 2025. Classification: OAI.

Violation Codes

21 CFR 803.50(a)(1)

21 CFR 806.10(a)(1)

21 CFR 820.100(a)

21 CFR 820.40(a)

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Record Information

Company

Abiomed, Inc.

Inspection Date

August 5, 2025

Product Type

Medical Devices & Rad Health

Office

Center for Devices and Radiological Health

ID: fae4cb66-ca26-4032-87c2-0eba597c4910

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