Fresenius, the German drugmaker, has received a warning letter from the US Food and Drug Administration targeting its Fenwal blood-products facility in Puerto Rico.
The FDA issued the warning following an inspection in April, which served as a follow-up to an earlier visit conducted in 2012.
Regulators found that the plant had repeatedly failed to document and investigate customer complaints relating to mislabelled bags, even after products had already been shipped to customers.
The agency made clear in its letter that the problems identified were not new, and should have been resolved months or even years before the latest inspection took place.
“Our inspection in 2012, and the current inspection, found that you have received multiple consumer complaints related to mislabeled bags, inadequate bag size, defective product components, and product mix-ups” that were left unresolved.
In a repeat violation, the Puerto Rico plant was criticised for failing to establish a written procedure to ensure products receive correct labels and to prevent mix-ups at the facility.
The labelling failures contributed directly to product recalls, with the company forced to pull its Adsol blood preservative as well as an anticoagulant solution from the market.
The Puerto Rico warning follows a separate and significant blow to Fresenius, which received a warning letter in July for a drug manufacturing plant located in India.
The pair of regulatory actions within such a short period signals growing scrutiny from the FDA toward Fresenius operations across multiple international manufacturing sites.
For Fresenius, the repeat nature of the violations identified at the Fenwal facility will be a particular concern, as regulators have little tolerance for problems that persist across multiple inspections without meaningful corrective action.
The FDA’s warning letters carry serious implications, potentially leading to import alerts, consent decrees, or further enforcement action if companies fail to respond adequately and correct identified deficiencies within a defined timeframe.