Assembly Contracts Ltd – FDA Inspection, Mar 25, 2026

Record Details

This FDA Inspection record concerns Assembly Contracts Ltd, with an inspection on March 25, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Assembly Contracts Ltd
Inspection Date: March 25, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Melanie W. Pishnery

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ID · 728a2cca-aad6-4b78-88cf-7c806e0b32da

Inspection Facts

Inspection number: 1309182
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.5.1Production controls not adequate

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FDA Inspection

Assembly Contracts LtdMarch 25, 2026