Oregon Compounder Warned on Multiple cGMP Violations
The FDA has warned an Oregon compounder for multiple GMP violations, including poor sterile drug manufacturing practices, using ingredients that aren’t FDA-approved and not receiving valid prescriptions for drugs it was producing.
According to the Jan. 27 warning letter, Creative Compounds failed to adequately clean and disinfect the room and equipment used to produce sterile products.
The company also did not have SOPs for producing sterile products and failed to ensure that its employees wore protective clothing.
The FDA also dinged the compounder for not having a system for monitoring environmental conditions at its Wilsonville, Ore., facility, and for lacking a written testing program for assessing drug stability. The investigator also cited the firm for not investigating batch failures.
Investigators from the FDA’s Seattle office further found the company produced drug products containing domperidone, which is not part of an FDA-approved human drug and not on a list of bulk drug substances that may be used for compounding.
The warning letter stems from an Aug. 4 through Aug. 28, 2014, inspection that prompted Creative Compounds to voluntarily recall all sterile drugs produced between July 1 and Sept. 22 of last year. The firm stopped compounding those products on Oct. 3.
The warning letter notes that the firm partially responded to FDA concerns by notifying the agency that it is no longer dispensing any compounded products that aren’t produced in response to a prescription. However, the company has not detailed steps it is taking to correct the GMP and misbranding issues. The FDA urged the firm to conduct a comprehensive assessment of its entire operation, including aseptic processing.
Creative Compounds did not respond to a request for comments by press time. View the warning letter at www.fdanews.com/02-12-15-OregonWarning.pdf. — Kellen Owings