Institute of Good Manufacturing Practices India®

The FDA issues Warning Letter to a Sterile Medicinal Products Manufacturer in the US

The FDA issued a Warning Letter to Cangene BioPharma, LCC, in Baltimore, a subsidiary of Emergent BioSolutions. Significant deviations from Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals are listed in the warning notice.

The drug products are meant to be adulterated according to section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B) as the facilities, methods, or manufacturing controls, packing, processing was not in accordance with CGMP.

The firm failed to maintain, clean, sanitize, and/or sterilize utensils and equipment at designated intervals to prevent contamination or malfunctions which could impact the strength, purity, and quality of the drug product. Also, the written procedures to clean and maintain the equipment were not followed.

The firm was not able to establish and adhere to suitable written procedures to prevent microbiological contamination of products meant to be sterile.