The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to November last year.
The recently released letter covers both the noted violations and a number of responses from the company it received from last November to February.
The FDA’s first noted violation was a failure properly validate manufacturing processes that cannot be verified post-production.
The agency noted two issues with the validation process for the manufacturing of the company’s extracellular bovine matrix-based devices, including its Xenform soft tissue repair matrices and a failure to demonstrate bacterial endotoxin testing of the devices.
In its second violation, the federal watchdog dinged the company for failing to establish and maintain procedures to prevent contamination of its equipment or products, specifically noting issues with its water system.
The FDA said that the company did not provide data showing it tests the water system it uses to produce extracellular bovine matrix devices for bacterial endotoxins. The agency added that TEI personnel informed that the company does not routinely perform microbial identifications on the bioburden recovered from the water system to identify the presence of gram negative and potential bacterial endotoxin contamination.
The federal watchdog said that it received responses from the company looking to correct the cited violations, but did not find the steps appropriate to resolve the issues, going as far as saying that the “deficiencies observed during our inspection are significant and demonstrate a systemic failure of your firm’s quality systems.”
The agency requested that the firm take further steps to correct the issues and said that it would require a re-inspection to ensure that the corrective actions were implemented.
In its third violation, the FDA noted several failures to control for environmental conditions, which could have an adverse effect on product quality.
The agency said that the company had not used sporicidal disinfectant in its ISO 7 clean rooms since March of 2017, adding that it identified spore-forming bacteria and fungal organisms during bioburden testing of its Xenoform product. Clean room gowns in the ISO 7 clean rooms were also noted as being re-used and “visibly dirty”, and personnel were not restricted from entering the cleaner manufacturing rooms after exiting higher contamination manufacturing rooms in the ISO 7 clean room, the FDA said.
The federal watchdog added that the company does not describe the frequency or process of cleaning the clean rooms with enough detail to prevent cross-contamination of separate areas during the process.
The agency said that it received a response outlining corrective actions to handle the violations, but said that it would need to verify them with a re-inspection.
In its final violation, the FDA said it noted a failure to maintain procedures for verifying or validating corrective and preventive actions to verify that the actions don’t adversely affect the finished products.
Again, the federal watchdog said it received a response to the issue that was inadequate, and requested more information on how the firm was correcting the issue.
The FDA gave the company the usual 15 business days to respond to the issues.