# FDA EIR - Holymed Products Co., Ltd. - June 19, 2019

Source: https://www.keypedia.com/records/eir/holymed-products-co-ltd/18cef160-d1dc-4d00-9b1b-3c5bcd2444da

> FDA EIR for Holymed Products Co., Ltd. on June 19, 2019. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Holymed Products Co., Ltd.
- Inspection Date: 2019-06-19
- Product Type: devices
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: A routine FDA inspection of Holymed Products Co., Ltd., a medical device contract manufacturer in Changzhou, China, was conducted from June 17-19, 2019. The inspection, focusing on Class I and Class II medical devices like surgical caps, shoe covers, and gowns, aimed to assess compliance with the FDA's Quality System Regulation. Two significant observations were noted on a Form FDA 483. First, the company failed to adequately establish and maintain procedures to control environmental conditions that could affect product quality (21 CFR 820.70(c)). This included not re-qualifying their "controlled environment area" since 2011, inconsistencies in environmental monitoring against established parameters, and a complete lack of environmental monitoring and cleaning records for Class I device production areas. Second, Holymed Products Co., Ltd. failed to maintain complete Device History Records (DHRs) for surgical caps manufactured prior to 2019, contrary to 21 CFR 820.184. Management acknowledged these issues, promising to implement corrective actions and provide a written response to the FDA within 15 business days. The inspection also noted a refusal by management to provide access to certain locked manufacturing and raw material storage areas, adding a layer of concern regarding transparency and control over all manufacturing operations.

## Related Documents

- [483 - 2019-06-19](https://www.keypedia.com/records/483/holymed-products-co-ltd/20a8ea68-17ad-4e4e-959a-956a5e5c5ba6)

## Related Officers

- [Shaquenta Perkins](https://www.keypedia.com/people/shaquenta-perkins/00369bbd-5784-42c2-847e-202c8b1b87a2)

Company: https://www.keypedia.com/companies/holymed-products-co-ltd/b73b5c31-5d73-48da-95f7-0777092db0d2

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4