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

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