Concha Inc. – FDA Inspection, Mar 27, 2026

Record Details

This FDA Inspection record concerns Concha Inc., with an inspection on March 27, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: Concha Inc.
Inspection Date: March 27, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office
Person: Nga T. Ho (Investigator)

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ID · 37b0813f-896e-4255-9f1a-5038a2c3e799

Inspection Facts

Inspection number: 1310020
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

ISO 13485:2016 Clause 5.6.1QMS not reviewed by top management at documented planned intervals
ISO 13485:2016 Clause 7.3.5Design and development reviews not performed
ISO 13485:2016 Clause 7.4.1Supplier evaluation and selection criteria do not include required elements
ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
ISO 13485:2016 Clause 7.3.3Design and development inputs do not include all requirements

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FDA Inspection

Concha Inc.March 27, 2026