FDA WARNING_LETTER - JAS Diagnostics, Inc./Drew Scientific, Inc. - April 28, 2022

**FDA Warning Letter Summary**

**Company:** [Company Name]

**Inspection Dates:** April 15, 2022 - April 28, 2022

**Main Violations/Issues:** 1. **Complaint Handling Deficiencies:** The company failed to establish adequate procedures for receiving, reviewing, and evaluating complaints. Specifically, complaints about damaged products during shipping were not properly documented or investigated. Of 25 complaints received, only one was documented and evaluated correctly. Additionally, the company did not maintain records for non-technical complaints from 2020, and many instrument complaints lacked necessary evaluations and documentation.

2. **Corrective and Preventive Action (CAPA) Inadequacies:** The company did not adequately establish CAPA procedures. Investigations failed to identify root causes or extend evaluations to other potentially affected products. For instance, CAPA 21-002 did not adequately investigate complaints about damaged products, and CAPA 21-001 did not fully explore issues with high background counts in test kits. CAPA 19-010 and 19-012 were closed without identifying root causes or completing investigations.

**Regulatory Framework:** The violations pertain to non-compliance with the Quality System regulation under Title 21, Code of Federal Regulations (CFR), Part 820, as mandated by the Federal Food, Drug, and Cosmetic Act.

**Required Actions:** The company must correct the noted deficiencies to comply with FDA regulations. This includes implementing adequate complaint handling and CAPA procedures, ensuring proper documentation and investigation of complaints, and conducting thorough root cause analyses. A follow-up FDA inspection is necessary to verify compliance.

**Response Status:** The company"s responses to the FDA"s observations are under review, but the adequacy cannot be determined as corrections are in progress. Further actions are required to address the identified issues.