Swami Medical, LLC – FDA Inspection, Jul 10, 2026

Record Details

This FDA Inspection record concerns Swami Medical, LLC, with an inspection on July 10, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.

Company: Swami Medical, LLC
Inspection Date: July 10, 2026
Product Type: Medical Devices & Rad Health
Office: Los Angeles District Office
Person: Juanj Wu (Issuing Officer)

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ID · 59ae3755-f7cf-4546-b814-8b962231d09e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1326128
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.3.3Design and development inputs do not include all requirements
ISO 13485:2016 Clause 7.5.7Processes for sterilization and sterile barrier systems not validated

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FDA Inspection

Swami Medical, LLCJuly 10, 2026