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FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
FDA sent a warning letter to Ecometics, Inc. after an inspection of the company’s Norwalk, CT facility found violations of current good manufacturing practices (CGMPs) that included a failure to establish and follow proper procedures for cleaning and maintenance of equipment. The inspection was conducted by FDA from August 17 to Sept. 7, 2018. According to FDA, violations were previously found at this facility during a September 2016 inspection.
The warning letter stated that the company had not demonstrated that its cleaning procedures were adequate to prevent cross-contamination between over-the-counter products and non-drug products. Inspectors observed drug products being manufactured on the same equipment as other products such as insect repellent, hair removal creams, and dyes. “Inadequate removal of residues from manufacturing equipment during cleaning can lead to contamination of drug products subsequently manufactured on the non-dedicated equipment. It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture toxic products such as insect repellent,” the agency stated. FDA requested the company discontinue manufacturing drug products on shared equipment with non-drug products and perform a risk assessment on previously manufactured drugs.
The company also failed to test for total aerobic microbial count and objectional microorganisms on products before releasing them to the US market. “Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes that are appropriate for their intended use, including microbiological specifications,” the letter stated. FDA asked the company to provide microbiological batch release specifications for each product, provide microbiological analysis for retain samples of drugs distributed to the US market within expiry, and specify actions the company will take in response to any adverse test results including customer notifications and product recalls.
In addition, the agency stated the company did not follow adequate written testing programs to assess stability. The agency is requiring the company provide a comprehensive, independent assessment and corrective action preventive action (CAPA) that includes a remediated standard operating procedure describing the stability program, stability-indicating methods for each drug product, an ongoing program in which representative batches of each product are added each year to the program to determine if shelf-life claims remain valid, and specific attributes to be tested at each time interval.