Company
IndonesiaSugih Instrumendo Abadi, PT., Padalarang, Jawa Barat, Indonesia – FDA Inspections
Inspection records and compliance data for Sugih Instrumendo Abadi, PT. in Padalarang, Jawa Barat. 3 FDA inspections on record, 2 Form 483s, 1 warning letter, last inspected March 12, 2026.
Company Profile
This profile covers Sugih Instrumendo Abadi, PT. based in Padalarang, Jawa Barat, Indonesia.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected May 14, 2009. Last inspected March 12, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR content1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 12, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1307998 |
| November 2, 2023 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1222583 |
| May 14, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 586556 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sugih Instrumendo Abadi, PT.
FEI Number
3002118752
Address
Jl. Tembokan Rt. 1/01, Ds. Cipeundeuy, Padalarang, Jawa Barat, Indonesia
Country
Indonesia
ID: 9de57864-dd12-4c4f-87b6-15d603fc35b2