FDA 483 - Swabplus, L.P. - July 25, 2023

**FDA 483 Summary: Swabplus, L.P.**

**Inspection Dates:** July 25, 2023 - August 1, 2023 **Location:** Rancho Cucamonga, CA **FEI Number:** 3003053677 **Report Issued to:** Man To "Andy" Ku, Chief Operating Officer

**Overview:** The FDA conducted an inspection of Swabplus, L.P., a contract repacker, identifying several compliance issues. These observations highlight deficiencies in the firm's adherence to regulatory standards designed to ensure product safety and quality.

**Main Violations/Issues:**

1. **Microbial Control:** The firm failed to follow procedures to prevent objectionable microorganisms in non-sterile drug products. Specifically, the sanitization of the purified water system was not performed as required by their internal procedures, marking this as a repeat observation.

2. **Data Integrity:** Inadequate controls over computer systems were noted, as audit trails from analytical instruments were not thoroughly reviewed, potentially allowing unauthorized changes to production and control records.

3. **Expiration Date Accuracy:** Drug products were labeled with expiration dates exceeding those supported by stability data, lacking scientific justification for such extensions.

4. **Quality Control Procedures:** Responsibilities and procedures for the quality control unit were not documented or fully adhered to, compromising the integrity of quality assurance processes.

5. **Documentation and Record-Keeping:** Deviations from written sampling plans and test procedures were not recorded. Additionally, document control procedures were insufficient, allowing unauthorized access and modification of GMP documents.

**Regulatory Framework:** These observations fall under the FDA's regulatory framework for ensuring drug product safety, quality, and compliance with Good Manufacturing Practices (GMP).

**Required Actions:** Swabplus, L.P. must address these observations by implementing corrective actions to ensure compliance with FDA regulations. This includes revising procedures, enhancing data integrity measures, ensuring accurate labeling, and strengthening documentation controls. The firm is encouraged to