FDA Inspection
Sugih Instrumendo Abadi, PT.Sugih Instrumendo Abadi, PT. – FDA Inspection, Nov 2, 2023
Record Details
This FDA Inspection record concerns Sugih Instrumendo Abadi, PT., with an inspection on November 2, 2023, issued by the Office of Inspections and Investigations.
- Company
- Sugih Instrumendo Abadi, PT.
- Inspection Date
- November 2, 2023
View Company Profile
ID · bd6a5df8-1564-4655-a407-94336b1d8383
Inspection Facts
- Inspection number
- 1222583
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
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Other FDA inspections of Sugih Instrumendo Abadi, PT.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| May 14, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sugih Instrumendo Abadi, PT.
- FDA Inspection 1307998 - 2026-03-12
- FDA Inspection 586556 - 2009-05-14
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