FDA Inspection 1307998 - Sugih Instrumendo Abadi, PT. - March 12, 2026

Record Details

This FDA Inspection record concerns Sugih Instrumendo Abadi, PT., with an inspection on March 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Sugih Instrumendo Abadi, PT.
Inspection Date: March 12, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations

Open in Dashboard

ID · d9931f82-1ffd-4dc8-87fe-36d6d7511ff2

Violation Codes4

ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 8.3.1ISO 13485:2016 Clause 8.5.2

Full citation text and observation details available on the Dashboard.