FDA Sends Warning Letter to California OTC Manufacturer

FDA sent a warning letter, dated July 3, 2018, to bB BioChem Laboratories Inc. after the agency inspected the company’s Santa Ana, CA facility from Dec. 12–18, 2017. FDA stated in the letter that the company was producing unapproved new drug products, and inspectors found violations of current good manufacturing practices (CGMP) that included a lack of quality control and stability testing.

Specifically, according to the agency, the company failed to establish a quality control unit or written procedures. “You lack a process for making an appropriate batch disposition decision. You also failed to establish systems and documentation for numerous basic drug manufacturing operations, including but not limited to, change control, complaints, supplier qualification, recalls, and annual product reviews,” the agency stated.

Batches of product were released without quality control testing to test the identity and strength of active ingredients. Specifications for finished drug products were not established. FDA asked the company to provide chemical and microbiological batch release specifications for each drug product, a commitment to test for conformance, chemical and microbial test methods for analyzing products, and a summary of test results.

According to the agency, the company also failed to test incoming raw materials for their identity, strength, and quality attributes. The company relied on certificates of analysis from unqualified suppliers. Written specifications for incoming materials were not established.

The company also lacked a stability program and written procedures. “In response to this letter, provide your plan, with timelines, to develop and implement a complete drug stability program. This plan should also include an assessment of the stability of drug products currently on the US market within expiry,” the agency stated.

FDA stated that the agency may withhold approval of pending drug applications or refuse requests for export certificates until the company corrects the violations. “We may re-inspect to verify that you have completed your corrective actions. We may also refuse your requests for export certificates,” FDA stated.

Source: FDA