# FDA WARNING_LETTER - Sugih Instrumendo Abadi, PT. - June 28, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/sugih-instrumendo-abadi-pt/5254e500-cd3b-4428-8cd7-a0546f392d6f

> FDA WARNING_LETTER for Sugih Instrumendo Abadi, PT. on June 28, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sugih Instrumendo Abadi, PT.
- Inspection Date: 2012-06-28
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: On October 22, 2012, the FDA issued a Warning Letter to Sugih Instrumendo Abadi, PT. following an inspection from June 25-28, 2012, at their Padalarang, Indonesia facility. The inspection revealed that the firm's aneroid sphygmomanometers (blood pressure cuffs) are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to control device design (21 CFR 820.30(a)):** The firm established a Design Control Procedure on June 8, 2012, but had not subjected the aneroid sphygmomanometer (cleared via 510(k) #K012444 in 2001) to this process.
2.  **Failure to establish adequate in-process acceptance procedures (21 CFR 820.80(c)):** Defective aneroid gauges, approved for transfer to the warehouse, were found in a rejected bin, with some undergoing rework multiple times due to calibration failure.
3.  **Failure to control production processes (21 CFR 82

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/sugih-instrumendo-abadi-pt/9de57864-dd12-4c4f-87b6-15d603fc35b2

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861