# FDA RESUME - Unknown Company - Unknown Date

Source: https://www.keypedia.com/records/resume/unknown-company/f5fbcf44-0f46-4f30-a2ce-a8bac026ea09

> FDA RESUME for Unknown Company on Unknown Date. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: RESUME
- Summary: The FDA inspection document pertains to Vaishali J Patel's role as a Quality Assurance Manager at Home Access, located at 2401 West Hassell Road, Suite 1510, Hoffman Estates, IL. The inspection focused on ensuring compliance with medical device regulations, specifically the current Good Manufacturing Practices (cGMP) under 21 CFR Part 820, which governs Quality Systems Regulation for medical devices.

Key violations identified during the inspection included deficiencies in the Corrective and Preventive Actions (CAPA) System, Change Management/Document Control System, Customer Complaint System, and the handling of Deviations/Nonconformances. Additionally, issues were noted in the Device History Record review and Product Release processes, as well as in the management of Quality/Regulatory records.

The regulatory framework requires the company to address these violations by implementing corrective actions to enhance total quality and prevent erroneous transactions. This includes actively managing processes to ensure compliance with cGMP, conducting internal audits, and following up on audit responses. The company must also ensure that all systems, processes, and products comply with applicable medical device regulations and company policies.

Required actions include the review and approval of documentation related to supplier quality status, coordination of the Material Review Board, and management of CAPA reports. Furthermore, the company must oversee regulatory records such as FDA site registration, Annual Reports, and UDI Labeling database requirements. Training personnel in cGMP concepts and maintaining training records are also essential to meet regulatory standards.

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## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)