Customed Warehouse Conditions Bring FDA Warning Letter

Customed, a Puerto Rican maker of convenience packs for surgical procedures, received a U.S. FDA warning letter for unacceptable warehouse conditions and other GMP issues.

In the finished goods warehouse, an investigator saw black and brown stains in the finished product area that appeared to be mold, as well as open windows and doors that lacked screens to keep bugs out. The FDA also saw expired products that were not segregated from products set for distribution, according to the Dec. 9, 2014, letter posted online Feb 10.

In the incoming and raw materials warehouse, the company stored product with “visible signs of deterioration” and no expiration dates, and again had open windows and doors without screens, the letter says. Meanwhile, there were inadequate gowning requirements for the manufacture of finished product and employees were seen assembling sterile and nonsterile convenience kits without wearing gloves.

The FDA also cited Customed’s performance requalification study, which lacked poststerilization inspections to check whether the sterilization would impact product function or package integrity. According to a final report, no physical inspection was ever conducted.

Customed also failed to adequately demonstrate that the terminally sterile medical packaging and product can make it through transit, handling and storage without negative effects on sterility.
During the July 14-31, 2014, inspection of Customed’s Fajada, P.R., facility, the devicemaker provided shipping validation documents from 2006 for convenience packs intended for cardiovascular and ophthalmic surgeries.

An FDA review of the company’s shipping validation protocol found it performed ethylene oxide validation using the outside cardboard shipping containers, but did not perform validation of the inside convenience packages following the EtO sterilization process.

Another sterilization-related citation involved a corrective and preventive action plan that was opened after a complaint related to saline bottles. The company decided to remedy the issue with a substitute item, but did not retrospectively review all components that had gone through the sterilization cycle to check compatibility with sterilization cycle parameters.

Customed was also rapped for failing to validate software it used to track product inventory, such as incoming materials, finished and released products and quarantine items. Further, the status of lots of finished products and incoming materials in the warehouse didn’t match the system inventory, according to the warning letter.

The FDA also chided Customed for its medical device reporting procedure, which lacked adequate systems for identifying and evaluating events. The procedure did not ensure timely transmission of complete MDRs or describe how the company will meet documentation and recordkeeping requirements. Customed did not respond to a request for comment by press time. The warning letter is available at www.fdanews.com/02-10-15-Customed.pdf. — April Hollis