The Lenoir, North Carolina facility was subject to an inspection by the US Food and Drug Administration (FDA) last November with a Warning Letter issued citing deviations from cGMP for its allergenic extracts, which are biological drug products.
“You failed to manufacture drug products in the manner described in your approved BLA [biologics license application],” the letter said, with Greer combining various types and amounts of its extracts to produce allergenic "custom mixtures." However, the letter continued “you have not obtained a license to manufacture and distribute these combined product mixtures.”
The company was also pulled up on its levels of hygiene: “You failed to maintain buildings used in the manufacture, processing, packing, or holding of your allergenic products in a clean and sanitary condition and free of infestation by insects,” the FDA said.
“Live insects were observed during and after filling operations. Further, your corrective actions implemented as a result of the investigations were inadequate in that live insects continued to be observed in these areas.”
Other issues cited by the FDA included the failure to perform general safety tests for the detection of extraneous toxic contaminants on biological products, failure to investigate any unexplained discrepancy or the failure of a batch, and failure to assure an adequate system for monitoring environmental conditions.
According to a publication on Greer’s website, the firm provides biopharma firms with allergenic source materials. “Most allergenic source materials are obtained from their natural environments. Ragweed and other pollens are collected from fields and processed to produce source material lots with high purity and confirmed identity.”
However, “other allergenic materials such as fungi, dust mites and some insects, must be produced from laboratory cultures using specific and highly-controlled growth and workup conditions.”