Quality Issues Found at Brazil Drug Manufacturing Facility

On August 25, 2016, FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A following an inspection of the company’s facility in Uberlandia, Brazil, performed from February 29–March 3, 2016. The company was cited for current good manufacturing practice (CGMP) violations specific to ensuring quality in their products. FDA placed the company on Import Alert 66-40 on July 15, 2016.

FDA inspectors found that the company had not established adequate written procedures for its quality control unit, including the review and approval of production and control records and the handling and review of out-of-specification investigations. The company also failed to perform microbiological testing on each lot of finished product.

Components, drug product containers, or closures were released that did not meet appropriate specifications for identity, strength, quality, and purity. Inspectors also found that expiration dates on products were not supported by stability data.

FDA stated in the letter that the company’s response to the FDA 483 was inadequate. “Although you committed to establish written procedures for quality unit responsibilities and stability studies, your response lacked details. You did not include a retrospective review of CGMP deficiencies on the quality of your products already in United States distribution,” the agency stated. FDA recommends the company hire a consultant to assist in meeting CGMP requirements.

Source: FDA