(Photo : U.S Food & Drug Administration)
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sani-Care Salon Products in Cartersville, California, following a recent inspection revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Conducted over four days from Oct. 31 to Nov. 3, 2023, the inspection highlighted significant deficiencies in the company's manufacturing processes, as reported by GMP Insiders.
Key findings included unsanitary conditions throughout the facility, raising concerns about potential product contamination. Specifically, the FDA noted failures in maintaining the water system used in drug production, lacking adequate validation and monitoring procedures.
Additionally, insufficient cleaning protocols were observed for both pharmaceutical and non-pharmaceutical products, coupled with inadequate equipment maintenance practices.
Further scrutiny revealed shortcomings in Sani-Care's quality control unit, which failed to ensure that drug products met required specifications for identity, strength, quality, and purity.
Critical lapses included incomplete batch production records that compromised process traceability and a lack of stability studies to determine product expiration dates, as well as the absence of necessary laboratory testing to verify product specifications.
Moreover, the FDA identified deficiencies in Sani-Care's testing of incoming components, relying on supplier certificates without adequate independent verification and using expired active pharmaceutical ingredients without appropriate testing.
In response to these findings, the FDA has mandated Sani-Care Salon Products to undertake comprehensive corrective actions.
These include validating their water systems, implementing robust cleaning procedures, conducting stability studies, enhancing laboratory testing protocols, and improving oversight of incoming component quality.
Failure to rectify these violations may result in further regulatory action, potentially impacting the company's ability to manufacture and distribute products in compliance with FDA standards.
Sani-Care has been instructed to respond promptly to the FDA detailing specific corrective actions taken to address these concerns and prevent recurrence.