Regulatory Focus™ > News Articles > Sterility Concerns Lead to Warning Letter, Import Alert for German Pharmaceutical Manufacturer

Sterility Concerns Lead to Warning Letter, Import Alert for German Pharmaceutical Manufacturer

Posted 20 May 2014 | By Alexander Gaffney, RAC

Sterility Concerns Lead to Warning Letter, Import Alert for German Pharmaceutical Manufacturer

The US Food and Drug Administration (FDA) has sent a Warning Letter to German-based pharmaceutical manufacturer SANUM-Kehlbeck GMbH & Co alleging that it violated current good manufacturing practices (CGMP) at its Hoya, Germany facility.

The company also failed to register its facility with US regulators in violation of Section 510 of the Federal Food, Drug and Cosmetic Act (FD&C Act), FDA charged in its 11 April 2014 letter to the company, released today.

The bulk of the letter, however, pertains to purported manufacturing problems at the plant. During a March 2013 inspection, FDA inspectors said they determined that the company's penicillin manufacturing operations were not properly segregated. Under an April 2013 guidance document, those drugs must be manufactured in separate areas to avoid cross-contamination with other products.

"As such, all non-penicillin products produced in your facility are potentially adulterated with penicillin, and constitute a potential serious allergenic hazard to patients who are sensitive to beta-lactams," FDA wrote. 

Elsewhere in the facility, FDA inspectors found fault with processes intended to preserve and ensure product sterility by preventing contamination. Inspectors said the firm had "not performed smoke studies under dynamic conditions," had not validated a piece of machinery used to produce sterile drugs and had failed to ensure that employees could "gown in an aseptic manner."

In several instances, FDA also took issue with the practices of employees at the facility, alleging that they had been seen with exposed skin around aseptically filled product. In other instances, FDA said it observed operators reusing gowning throughout the day and using some gowning components like masks, hair and beard covers that were not required to be sterile.

"These questionable practices raise concerns regarding your firm’s understanding of basic aseptic process controls that are needed to prevent the introduction of microbial contamination into an aseptically filled product," FDA wrote.

In addition, FDA said SANUM-Kehlbeck employed persons in a microbiological testing capacity who did not possess a microbiology background. Under 21 CFR 211.25(a), those employees must have received specialized training prior to working in certain capacities.

FDA gave the company 15 days to return a response to the agency, and said until deviations are corrected, FDA will refuse to admit the company's products into the US.

Warning Letter to SANUM-Kehlbeck

Categories: Regulatory News

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