German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients.

The non-penicillin products could be contaminated with penicillin, the FDA said in warning letter released Tuesday, which stems from the agency’s March 2013 inspection of the company’s Hoya, Germany, facility.

Sanum recalled 56 lots of products derived from penicillium in March 2014 because they may have undeclared penicillin. However, the FDA asserted more needs to be done to address the problem. The company needs to describe all the actions it will take to prevent potential contamination of non-penicillin products, the letter reads.

The FDA also detailed several good manufacturing practice (GMP) violations at the facility. The drugmaker had been put on import alert in July 2013 for failing to meet GMPs.

Investigators discovered that operators routinely reused gowning throughout the day for sterile activities. Additionally, the company failed to require that all components of the gowning remain sterile, including masks and hair and beard covers, the letter says. “Our investigators also observed gowned personnel in the aseptic filling areas with exposed skin,” it adds.

Sanum responded that it will purchase sterile masks and not allow gowning to be reused. However the response didn’t address the operators’ exposed skin, the letter reads.

The FDA also chided Sanum for not maintaining its registration that enables imports of drug products into the U.S. Sanum also failed to keep up a complete and accurate drug product listing with the agency.

The lapses could result in the FDA stopping Sanum imports because they are misbranded, the letter reads.

Sanum did not return a request for comment as of press time.

Source: FDA News