FDA Issues Warning Letter to OTC Drug Manufacturer Over Major cGMP Violations

On September 23, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an over-the-counter (OTC) drug manufacturer in Glendale, California, Person & Covey, Inc. following an inspection that uncovered multiple serious current Good Manufacturing Practice (cGMP) violations.

The FDA cited analytical data integrity issues, including disregarded out-of-specification (OOS) results, uncontrolled analytical software access, and lack of formal data integrity procedures. Stability failures were reported for three OTC products, with inadequate investigations and premature closure of OOS reviews. The firm made formulation changes without process validation or stability data, and its Quality Unit failed to exercise proper oversight, allowing rework of a sunscreen batch without approval.

Additionally, two products were marketed as unapproved new drugs for hyperhidrosis.

The FDA requires the company to submit a corrective and preventive action (CAPA) plan, validated by an independent consultant. Failure to comply could result in recalls, import alerts, or withholding of approvals, emphasizing the importance of robust quality systems.

06-10-2025