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

Source: https://www.keypedia.com/records/warning_letter/osachi-co-ltd/1db0241c-6d1a-485e-aec6-0c324a98504a

> FDA WARNING_LETTER for Osachi Co. Ltd. on August 09, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Osachi Co. Ltd.
- Inspection Date: 2012-08-09
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [James R. Greenwood](https://www.keypedia.com/people/james-r-greenwood/a6385596-570c-4d0f-b911-140b72a9ecbf)

Company: https://www.keypedia.com/companies/osachi-co-ltd/00e1d424-5f1a-42f2-a030-3b37bc3b4976

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7