# FDA WARNING_LETTER - Meridian Co., Ltd. - May 29, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/meridian-co-ltd/91df6d84-b9cf-4ef1-a151-ea459564df65

> FDA WARNING_LETTER for Meridian Co., Ltd. on May 29, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Meridian Co., Ltd.
- Inspection Date: 2014-05-29
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 19, 2014, the FDA issued a Warning Letter to Meridian Co., Ltd. following an inspection from May 26-29, 2014, which found their infrared lamps and plethysmographs to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's June 12, 2014 response to the FDA 483 was deemed inadequate.

Key violations include:
1.  **Complaint Handling (21 CFR 820.198(a)):** Failure to classify product malfunctions as complaints, evaluate for MDR reportability, and provide documentation of revised procedures and training.
2.  **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** CAPA procedure lacked verification/validation requirements, and nonconformance reports were not analyzed for root causes. Response lacked implementation documentation.
3.  **Purchasing Controls (21 CFR 820.50):** Exempted components from supplier qualification without specification, lacked contracts with major suppliers, and failed to maintain records of acceptable suppliers. No corrective action description provided.
4.  **Equipment Calibration (21 CFR 820.72(

## Related Officers

- [Samuel Kim](https://www.globalkeysolutions.net/people/samuel-kim/0d9bc58b-df65-419a-a289-b91d0490793f)
- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/meridian-co-ltd/cbf6177b-9c18-47ab-9679-cec3d4ef608a

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