Mar Cor Purification has received a warning letter from the U.S. Food and Drug Administration regarding manufacturing issues at its Plymouth, Minn. plant.
According to the letter, dated April 17, 2014, an inspection of the firm on Jan. 29 – Feb. 18 revealed several issues, including:
- Failure to adequately establish procedures for corrective and preventive action (CAPA).
- Failure to adequately establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
- Failure to investigate, where necessary, complaints involving the possible failure of a device to meet any of its specifications.
- Failure to adequately establish document control procedures.
The FDA letter said the agency received responses from Mar Cor dated March 7 and March 20. The agency said the letters provide updated complaint handling procedures but do not provide an updated CAPA procedure for review. Implementation of corrective actions will require verification during the FDA's next inspection, the agency wrote in the letter.
The FDA inspection also revealed that the Millenium HX and Central Water System (CWP) products are misbranded. The agency also said Mar Cor changed valve suppliers for the device after receiving several complaints of leaking and water issues, but did not submit the required written report to the FDA.
Representatives from Mar Cor have not yet responded to NN&I's request for comments.