# FDA 483 - Bard Shannon Limited - November 21, 2018

Source: https://www.keypedia.com/records/483/bard-shannon-limited/bd4558d3-f90d-42b4-9c71-c19765e671e1

> FDA 483 for Bard Shannon Limited on November 21, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bard Shannon Limited
- Inspection Date: 2018-11-21
- Product Type: devices
- Office Name: San Juan District Office
- Summary: An FDA inspection conducted from October 22 to November 21, 2018, at BARD SHANNON LIMITED, a medical device manufacturer in Humacao, PR, revealed multiple deficiencies in its quality system. The observations, outlined in an FDA Form 483, indicate non-compliance with the regulatory framework governing medical device production. Key violations include systemic failures in the Corrective and Preventive Action (CAPA) system. The company did not consistently extend corrective actions to all potentially impacted products, failed to adequately analyze quality data, and neglected to implement proposed actions, such as mandatory employee training. Production processes showed non-conformity, stemming from inadequate documentation practices, including improper raw data labeling and unverified log entries. Further issues involved insufficient control over validated process parameters, evident from shared user credentials and unauthorized data manipulation on testing equipment. The firm also failed to re-evaluate validated manufacturing processes after equipment software changes. Environmental control procedures were not followed, with no documented evidence of routine cleaning in manufacturing areas. Acceptance activities exhibited deficiencies like incomplete incoming component inspection records and inconsistent temperature monitoring. Lastly, equipment maintenance was inadequate, and device history records lacked complete documentation for in-process inspections. BARD SHANNON LIMITED is required to address these observations by implementing comprehensive corrective actions to ensure full compliance with established quality system regulations.

## Related Documents

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## Related Officers

- [Plant Manager](https://www.keypedia.com/people/juan-felipe-mendez-lopez/161a3623-43cd-40b2-b3e7-9a251eed6967)
- [Nydia E. Colon](https://www.keypedia.com/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)
- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/bard-shannon-limited/b5acb6e6-fd8b-4125-86ca-f353832e322c

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8