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FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.
FDA sent a warning letter, dated Sept. 24, 2020, to LEC Custom Products after an inspection of the company’s Brampton, Ontario facility in March 2020 found a variety of violations of current good manufacturing practices (CGMP). The violations included the use of inappropriate equipment and processes, a lack of written procedures for production control, failure to properly prevent contamination, a lack of a written testing program to assess stability of drug products, a failure to test components for identity and conformity to specifications, and a lack of an adequate quality control unit.
In the letter, FDA stated that the company failed to meet USP requirements and did not routinely test microbial attributes of its systems. “Additionally, because the main component in your non-sterile drug products is (b)(4), there is a potential risk of objectionable microbial contamination, such as Burkholderia cepacia (B. cepacia), which your firm did not test for as part of your microbial testing of the (b)(4) system,” the letter stated.
The company also did not follow through on corrective actions for process validation it had planned after a previous agency inspection. It also, according to the letter, did not have adequate control of its systems. “(b)(4) was used as the main component in the manufacture of your drug products. You lacked validation studies for your (b)(4) system. Your firm did not demonstrate that you could effectively design, control, maintain, and monitor the system, so it consistently produced pharmaceutical grade (b)(4) that, met the USP monograph for (b)(4) and appropriate chemical and microbial limits at a minimum.” FDA requested the company provide a summary of its validation program, a timeline for performing process performance qualification, and qualification protocols and written procedures.
In addition, the company’s equipment and utensils were not properly cleaned and/or sterilized, according to FDA. “You manufacture multiple OTC drug products on shared equipment. During the inspection, you informed us no cleaning validation data was available for your manufacturing and filling operations. You committed in writing to performing cleaning validation activities after previous FDA inspections. However, you did not follow through with your promised corrective actions,” the letter stated.
FDA placed the company on Import Alert 66-40 on July 14, 2020. “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” the letter stated.