# FDA 483 - San-M Package Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/san-m-package-co-ltd/b71f75d7-3be8-4776-a577-e2582f63a709

> FDA 483 for San-M Package Co., Ltd. on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: San-M Package Co., Ltd.
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of SAN-M Package Co. Ltd., a contract manufacturer of surgical masks, identified two significant observations. The firm failed to adequately establish procedures for corrective and preventive action, specifically lacking evidence of risk assessments for customer complaints. Additionally, the device history records for surgical masks did not include or refer to the location of labeling information.

## Related Officers

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Company: https://www.keypedia.com/companies/san-m-package-co-ltd/c395efb9-b12e-48b8-af96-f676bee14f0f

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd