FDA WARNING_LETTER - Jamol Laboratories, Inc. - January 12, 2023

The FDA inspected Jamol Laboratories, Inc. (FEI 2211383), a manufacturer of the OTC drug Ponaris® NASAL EMOLLIENT, from December 2022 to January 2023. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, leading to the adulteration of their drug products under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act. Specifically, the facility's manufacturing space was found to be insanitary, disrepaired, poorly cleaned, and maintained, with observations including a dead insect, exposed ceiling, and inadequate ventilation, indicating a lack of controls to prevent contamination. Key CGMP violations included an inadequate quality control unit (21 CFR 211.22) that failed to provide sufficient oversight, lacked essential procedures for roles and investigations, and approved incomplete batch records. The firm also failed to establish adequate laboratory controls (21 CFR 211.160(b), 211.165(b)), specifically lacking a specific identification test for Eucalyptus Oil and conducting insufficient microbiological testing for the drug product, without assessing for aflatoxins/mycotoxins. Furthermore, Jamol Laboratories failed to establish written procedures for production and process control (21 CFR 211.100(a)), neglecting to validate manufacturing processes for Ponaris or implement an ongoing process control monitoring program. The firm's responses to the FDA 483 were deemed inadequate, failing to provide holistic reviews, scientific justifications, or comprehensive validation plans. Jamol Laboratories is required to provide a detailed response within 15 working days, outlining corrective actions, including comprehensive assessments, CAPA plans, and full testing of retain samples. Failure to address these violations promptly may result in severe regulatory actions, including seizure, injunction, and impact on export certificates and new drug application approvals.