German drugmaker Fresenius received a scathing warning letter in July for a drug plant in India. Now, a blood-products plant in Puerto Rico has been sent a warning for a labeling issue which the agency said should have been resolved months, even years ago.
The FDA Tuesday posted the letter that the drugmaker's Fenwal operation received for an inspection in April, a follow-up to a 2012 visit. Primarily, the agency was concerned about the company's failure to document and investigate customer complaints about mislabeled bags even although the products had already been shipped. "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.
Further, in a repeat violation, the plant was criticized for not writing a procedure to make sure that products get the right labels and procedures to "prevent mix-ups and cross-contamination" by keeping different products separated from each other, even though the facility has been getting complaints since 2010 about the problem. The agency was also upset that the plant still wasn't submitting field alert reports, or FARs, even though it was told in 2012 that it needed to. As a result, the company now is having to recall its Adsol blood preservative as well as an anticoagulant solution, the FDA pointed out.
The agency focused in on the plant's quality control unit, saying it was relying on customers to identify problems that should have been corrected at the plant. The complaints show that the unit is not "fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product(s)," the letter says.
In July, the company's oncolytic API plant in Kalyani, India, was savaged in a warning letter that said employees lied about having blended APIs that failed quality tests into batches that passed in an effort to hit specifications. It documented employees confessing to manipulating data to hide problems from the agency. They told inspectors that when it was known there was going to be an inspection, high-pressure liquid chromatography equipment and personnel computers were removed from the plant to "conceal data manipulations."
The company followed up by firing the manager and other employees said to be involved, submitting a remediation plan and hiring outside consultants to help get its house in order.
- read the letter