BioMerieux Gets Warning Letter on Nonconformances, CAPA Trending
BioMerieux received a warning for its handling of complaints and nonconformances, including using roughly 546 complaint description codes that are not defined in company documents.
“The impact of this lack of definitions for the error codes is compounded by the fact that many of the error codes are similar,” according to the Oct. 10 warning letter.
The company’s Hazelwood, Mo., facility also failed to adequately review and evaluate all complaints. Between Jan. 1, 2013, and July 15, BioMerieux closed 18,926 complaints and replaced failed components, but did not thoroughly investigate why the component failed.
“Your complaint investigation stopped when the component was replaced,” the letter notes. “The investigation did not include attempting to determine if the failure was due to design, production, supply, or assembly issue or due to some other quality issue.”
BioMerieux did not appropriately analyze service reports after service visits that typically involved the replacement of at least one device component. “Each of these service visits is a critical data point documenting the postmarket failure of the device to function as designed,” the letter notes.
CAPA trending was also inadequate. For 39 production hardware failure nonconformances, the company decided not to open a CAPA because “NCMRs are trended periodically and CAPAs are issued according to this trending.” However, the nonconformances documented failures with different causes, “and your trending is only to the hardware component and not to the specific failure, when a hardware component can have any number of failure causes.”
Meanwhile, the company failed to re-validate an “In-Place” cleaning process after new reagents were added to the manufacturing process. The revalidation should have ensured the cleaning would prevent cross-contamination of biological culture media between production runs after the addition of the new reagents.
Furthermore, BioMerieux design transfer process did not specify the expiration acceptability of chemicals used to make microorganism identification cards. During design verification testing, the company used chemicals that were not close to expiration. However, the current manufacturing instructions allowed the use of chemicals that were set to expire the next day.
BioMerieux released to production, processing instruments capable of calibration but labeled them as “Calibration Not Needed” without justifying why a calibration was unnecessary. The machines are used to make media for the production of identification and antibiotic susceptibility testing cards.
The company also implemented three non-validated, in-house test methods in the manufacture of identification/susceptibility cards. “When your firm creates its own test method, your firm must validate the test method to prove the accuracy and reproducibility of the test method,” the letter says.
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