By Tyler Patchen
News Reporter
https://endpts.com/fda-warns-sure-biochem-over-quality-and-data-issues/

A warning letter has been given to a company that tests finished drug products over several quality issues.
The FDA issued the warning letter to Sure-BioChem Laboratories, a Camden, NJ-based contract test laboratory that does microbial testing on products including finished drugs. Sure-BioChem was inspected late last year, but the regulator has advised the company that it still needs to make some corrections.
The letter said that inspectors found that the company had failed to establish and follow procedures for some of its tests and it had not validated its use of “alternative microbial methods” used to test drug products to ensure that its methods were
“Specifically, you failed to adequately establish that your microbiological testing methods can reliably detect objectionable microorganisms,” the letter said.
Sure-BioChem’s methods also failed to detect Burkholderia cepacia complex (Bcc) bacteria and reported “not detected” to a client. The bacteria can cause serious respiratory infections in patients with cystic fibrosis and other chronic lung diseases.
The laboratory had previously responded to the agency that it’s revising its procedures. It also allowed that its alternative method to test drug products was not sufficient to test for Bcc. But the FDA took issue with the company’s response.
“Your response is inadequate because it does not address how you will review the validity of previous results using your alternative methods, or how you will communicate with your clients about these potentially noncompliant analyses,” the letter said. “You also state that you will perform method suitability verifications for each type of product, but do not detail the actions you would take if suitability verifications are found inadequate.”
The company now has to do an independent assessment of its laboratory practices, producers, and documentation; investigate inaccuracies in its data and records; and ensure it is properly testing for all microorganisms, including Bcc, among other steps.
The letter also said that the site’s quality unit did not have proper control over its testing operations and did not ensure that “suitable procedures” were in place. The quality unit also failed to have documentation on laboratory testing materials and did not establish proper training programs. In its response, the company admitted to not adhering to standard operating practices and said it is bringing in a consultant to develop a training program, but the FDA noted that the company did not do a comprehensive review to ensure that its testing materials were suitable.The letter also said that the lab was missing several pieces of testing data. And while Sure-BioChem said that it would revise its records to include any missing information, the FDA noted that there was no commitment to review any of its prior tests.
The letter also said that the lab was missing several pieces of testing data, including records of testing, testing results, equipment used and raw data, among other data points. And while Sure-BioChem said to the FDA that it would revise its records to include the missing information, the FDA noted that there was no commitment to review any of its prior tests.
The FDA recommends that Sure-BioChem brings in a CGMP consultant and follow guidelines when it comes to data.
Endpoints News reached out to Sure-BioChem for more information but did not immediately get a response.