Staff not trained, nor do they follow procedures, FDA says
The US Food and Drug Administration has issued a warning letter to injectable drugs manufacturer Hameln Pharmaceuticals after an inspection last June identified ‘significant violations of cGMP’ regulations for finished pharmaceuticals at its facility in Hameln, Germany.
Steven Lynn, director of the FDA’s Office of Manufacturing and Product Quality, said in the letter to Hameln Pharmaceuticals’ MD Christoph Kerstein, posted today on the FDA’s website, that Hameln’s responses in July, August and September lacked sufficient corrective actions.
The FDA inspection observed that some employees were not properly trained, that one could not read and accurately record microbial counts, while others in the sterile filling rooms did not follow procedures for changing their gloves as needed, handling dropped objects and taking samples.
The US regulator also said Hameln had not established or followed procedures to prevent microbiological contamination of drug products purporting to be sterile. Smoke study videos were not sufficient to evaluate the quality of the firm’s Class A airflow and an adequate system for monitoring environmental conditions in aseptic processing areas had not been established. In addition, Hameln’s in-house sterility testing method was not equivalent to or better than USP <71>.
The FDA said it wanted Hameln to document the specific steps it has taken to correct and prevent a recurrence of these violations, and provide supporting documentation within 15 days of receipt of the warning letter.