Florida Facility Receives FDA Warning Letter

FDA sent a warning letter, dated Feb. 28, 2019, to ANDAPharm, LLC after inspectors found violations of current good manufacturing practice (CGMP) procedures at the company’s Fort Lauderdale, FL facility. During the inspection, which occurred from July 10–18, 2018, the agency found CGMP deficiencies in the company’s cleaning procedures, stability testing program, and contamination control systems.

Specifically, the letter states that the company’s cleaning and maintenance procedures are not adequate to prevent cross-contamination, including an exhaust system that had not been cleaned in more than 10 years. According to FDA, the company’s lack of a cleaning validation plan is a repeat violation from previous inspections. The agency requested ANDAPharm provide a comprehensive plan to evaluate cleaning procedures, scientific rationale for the validation strategy, and a plan to determine the identity and reduce the amount of accumulated product residue.

The stability testing program violations found in 2018, which included missing data in stability summary reports, were also a repeat of violations found in previous inspections. The agency requested the company provide a summary of all accelerated and long-term stability data to support expiration dates of product, an assessment of the impact of missing stability data on product quality, and corrective actions and preventive actions to ensure stability.

FDA also stated that the company failed to prevent contamination or product mix-ups. “We observed rejected lots of phenazopyridine, salsalate, chloradiazepoxide/clindium bromide in your receiving area. These lots were not labeled as ‘rejected’ nor were they recorded as ‘rejected’ in the Reject Log Book. As a contract manufacturer, it is important that you maintain adequate control over your material flow and segregation to avoid potential mix-ups and release of rejected lots,” the agency stated.

Source: FDA