FDA WARNING_LETTER - Osachi Co. Ltd. - August 09, 2012

On November 13, 2012, the FDA issued a Warning Letter to Osachi Co. Ltd. following an inspection from August 6-9, 2012, which found their non-invasive blood pressure monitors (PADCHEK ABI/PVR) to be adulterated and misbranded. The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish adequate CAPA procedures (21 CFR 820.100(a))**: Procedures lacked requirements for verifying/validating CAPA effectiveness and disseminating quality problem information. 2. **Failure to maintain adequate complaint files and procedures (21 CFR 820.198(a))**: Complaint handling procedures did not require evaluation for Medical Device Reporting (MDR) under 21 CFR 803. 3. **Failure to establish adequate design verification procedures (21 CFR 820.30(f))**: Design verification raw data and summary reports lacked dates and signatures of individuals performing/reviewing activities. 4. **Failure to establish adequate purchasing data (21 CFR 820.50(b))**: Purchasing documentation for a key component lacked an agreement requiring the supplier to