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FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
FDA sent a warning letter, dated July 17, 2017, to Sage Products, Inc. in response to an inspection of the company’s Cary, IL facility conducted from June 2 to Sept. 1, 2016. Investigators found CGMP deficiencies in the company’s test methods, sampling plans, and sterilization procedures.
Specifically, FDA inspectors found that the company had failed to properly establish and document test methods. According to the agency, the company’s testing method had failed to detect microbial contamination. “You use the (b)(4) method to screen for microbiological contamination in drugs produced entirely at your facility and those manufactured under contract. This (b)(4) screening method (b)(4) for microbiological examination of your liquid drug products is not adequate for its intended use. You attempted to validate your (b)(4) microbial detection method, but were not able to demonstrate that it could reliably and repeatedly determine whether objectionable microorganisms were present in your drugs,” the letter stated.
Customer complaints were received regarding product discoloration, and further testing of the product revealed contamination. “The microbiological screening method on which you rely to examine your products for the presence of microbiological contamination has not consistently and reliably detected the presence of B. cepacia in your drugs before you released them for distribution … Had your firm been utilizing a screening method capable of consistently detecting B. cepacia, these products may not have been released in the first instance,” FDA stated.
The company also failed to establish appropriate sampling plans, test procedures, and sterilization practices. FDA is asking the company to comprehensively evaluate the adequacy of its cleaning and sanitization procedures, provide an improved sampling plan, and summarize a global corrective action and preventive action plan.