FDA WARNING_LETTER - Gadal Laboratories Inc. - February 17, 2023

The FDA inspected Gadal Laboratories Inc. from February 13-17, 2023, identifying significant CGMP violations, rendering their drug products adulterated. The firm failed to validate component supplier test analyses, particularly for pediatric OTC products. Issues included using unqualified suppliers for active ingredients like (b)(4) without establishing COA reliability, inadequate microbiological testing for (b)(4) excipient (a known source of *Clostridium botulinum*), and lacking specific identity tests for (b)(4) and (b)(4) in high-risk components.

The firm also failed to adequately validate production and process controls, including incomplete process validation studies and uninvestigated OOS results. Their (b)(4) system qualification was insufficient, and cleaning processes lacked thorough validation, relying solely on pH testing without detecting cross-contamination or microbial traces.

The Quality Control Unit demonstrated inadequate oversight, evidenced by unauthorized inactive ingredient substitutions without scientific rationale or stability studies, and the use of multiple specification ranges. Data integrity issues were noted, with raw data recorded in pencil, on uncontrolled sheets, and altered with correction fluid.

The FDA recommends engaging a CGMP consultant due to the systemic nature of the violations and the ineffective quality system. Gadal Laboratories Inc. must promptly address all deficiencies, including providing detailed corrective action plans, risk assessments for distributed products, and ensuring the Quality Unit has proper authority and resources. Failure to comply may result in regulatory action, including seizure,