FDA 483 - Lohxa, LLC - August 03, 2023

**FDA 483 Summary for Loxha, LLC**

**Company Name:** Loxha, LLC **Inspection Dates:** July 17, 2023 - August 3, 2023 **Location:** 600 Main St Ste 110, Worcester, MA 01608-2061 **Type of Establishment:** Repackager

**Main Violations/Issues:**

1. **Inadequate Investigation of Discrepancies:** Loxha, LLC failed to thoroughly investigate unexplained discrepancies and batch failures. For instance, a power outage on July 20, 2021, lacked a documented investigation into its root cause and potential product impact. Additionally, investigations into complaints about mupirocin ointment were insufficient, failing to assess quality checks and validate leak testing methods.

2. **Microbial Contamination:** The firm inadequately investigated out-of-specification microbial results for Senna syrup, with repeated contamination by Aerococcus viridans. The root cause was not identified, and environmental factors were not evaluated, raising concerns about the firm's ability to safely repackage the product.

3. **Deficient Complaint Records:** Loxha, LLC did not maintain proper complaint records, with missing documentation for several investigations. This issue was noted as a repeat observation from 2019.

**Regulatory Framework:** The observations fall under the FDA's regulatory oversight for ensuring compliance with Good Manufacturing Practices (GMP) and proper documentation and investigation procedures.

**Required Actions:**

- Conduct thorough investigations into all discrepancies and batch failures, identifying root causes and implementing corrective measures. - Validate testing methods and ensure all quality checks are effective and documented. - Maintain comprehensive complaint records and perform risk assessments as per company procedures. - Address repeat observations to demonstrate compliance and prevent future violations.

The FDA expects Loxha, LLC to address these issues promptly to ensure product safety and regulatory compliance.