FDA faults Japanese manufacturer with data breach, contaminated injectables

26 Aug 2021
endpts.com
The FDA has come down hard on a Japanese manufacturer , with cGMP failures that include batch discrepancies left without investigation, data breaches left unaddressed and the manipulation of contact plate measurements. Toyobo Co. received a warning letter on Aug. 19. If it cannot correct the violations, the FDA can refuse the import of drugs manufactured at the Shiga site into the US. Toyobo has 15 days to respond to the letter. Between 2019 and 2020, foreign objects were found in batches of an injectable produced at the site, and Toyobo didn’t investigate the root cause of the contamination soon enough, nor did it try to assess the impact the contamination could have. While the company has now hired outside auditors and consultants to fix up its operation, the investigation found that the washing and sterilization process couldn’t remove particles on stoppers and vials, and the root of that problem has still not been addressed, the FDA said. “Our review revealed that your in-process quality standards, limits, categories, and triggers for investigations do not sufficiently differentiate intrinsic from extrinsic particulate contamination,” the warning letter says. There were 12 batches that had cellulose and glass fibers, stains, and particles on vials, the FDA said. Among the most egregious offenses, the company failed to ensure the accuracy and integrity of the data, which can lead to fluctuating safety, efficacy and quality of the drugs. Particle data was misreported when the levels were higher than alert levels, and operators were involved in the manipulation of data, the letter said. The weaknesses could have impacted batches dating all the way back to 2016. “Awareness of microbial excursions in an aseptic processing operation is essential to trigger prompt actions that maintain environmental control. Additionally, timely and thorough evaluation of action level excursions, identifying potential routes of contamination, as well as identifying appropriate follow-up measures are necessary to prevent contamination risks to the product,” the FDA said. “Your failure to report accurate data compromised the sterility assurance of drug products released from the facility and may have increased risks to patients.” Toyobo said its employees’ lack of understanding of cGMP and the importance of data integrity, and an inability to handle the pressure of deviations are to blame for the slip-ups. The FDA said that in order to resume operations, the company needs to improve staff accountability, and enact a plan to do so. The company must provide an assessment of all human interaction in the contaminated area, air quality, facility layout, personnel and material flows and equipment placement.
Organizations
Indications
-
Targets
-
Drugs
-
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.