FDA hits Japanese CMO with warning letter

Aug. 27, 2021

Toyobo Co., a contract manufacturer in Japan, has been slapped with a warning letter from the FDA for quality issues related to sterile drug production.

In the letter, dated Aug. 19, 2021, posted this week, the agency chided the company for not adequately investigating particle defects and contamination in its sterile drug products. 

“Multiple batches of (b)(4) injection solution were found to have significant particulate contamination defects, many of which are defined in your procedure and response as “foreign” (i.e., extrinsic),” the FDA explained. But, the agency added, the company failed to determine root causes for those defects or differentiate intrinsic from extrinsic particulate contamination. 

The agency said it inspected the company’s facility in Otsu, Shiga three times in February of this year, and afterward, the company did improve its quality procedures and supplier audits, but its root cause analysis and CAPA implementation are still not up to snuff. 

In particular, the FDA said that Toyobo failed to adequately explain the presence of visible particulates including cellulose and glass fibers, and stopper “stain” defects. After the company’s stopper supplier said it wasn’t their fault, the FDA noted that Toyobo failed to find another cause. 

The FDA has now asked Toyobo for an independent assessment of its investigation systems along with an action plan to remediate this system. 

Toyobo, which the company says was founded in the late 19th century as a textile maker, produces a range of products for the chemical, textile, cosmetics and pharma industries, along with contract manufacturing services for biopharma.