FDA WARNING_LETTER - Swabplus, L.P. - April 11, 2019

The FDA issued a Warning Letter to Swabplus L.P. following an inspection from March 19 to April 11, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Component Testing:** Failure to test incoming components, including active ingredients like benzalkonium chloride, for identity, purity, strength, and quality. The firm relied on unqualified supplier COAs and did not validate supplier test analyses, a repeat violation from a 2016 inspection. 2. **Inadequate Water System Monitoring:** Failure to routinely monitor the water system used in OTC drug products for required quality attributes and adhere to minimal monitoring schedules. 3. **Unsuitable Microbial Test Methods & Inadequate Method Validation:** Lack of growth promotion testing for prepared media and failure to neutralize anti-microbial preservatives during finished product microbial testing. The firm also used unvalidated non-compendial analytical methods for active ingredient assay. 4. **Inadequate Quality Control Unit (QCU):** The QCU lacked appropriate change management procedures and failed to timely investigate a prolonged UV light failure in the water system, continuing to use unassessed water. 5. **Inadequate Computer System Controls:** Failure to establish unique user names for laboratory equipment (HPLC, FTIR) and properly maintain backup copies of original data, citing "legacy equipment" as an inadequate excuse.

The FDA requires comprehensive corrective