Allergen Manufacturer Warned for Unapproved Drugs, Insect Infestation

May 9, 2014

The FDA slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts.

The warning letter, released by the agency Tuesday, is a follow-up to a Form 483 issued to Greer after the FDA’s November 2013 inspection of its Lenoir, N.C., facility, which manufactures allergenic extracts and allergy immunotherapy products.

The agency charged Greer with combining various types of allergenic extracts to form “custom mixtures” that weren’t approved by the FDA. Greer responded that it has made these mixtures for some time, and that the FDA allows such mixes in response to a prescription.

“Regardless of whether or not FDA has objected to the manufacture of prescription sets after receipt of a physician’s prescription for a specific patient, the FDA investigator noted that Greer’s current manufacture of these mixes is not linked to specific patients,” reads the April 21 letter.

The FDA also chided Greer for several good manufacturing practice (GMP) violations, including the presence of live insects in the aseptic filling suite during and after filling operations.

Greer’s corrective actions weren’t adequate, as live insects continued to be found in these areas, the letter reads.

Investigations into drug product lots that failed a general safety test for toxic contaminants were also inadequate, the FDA said. While Greer identified contaminated batches and rejected the defective lots, the company took too long to conduct an investigation and didn’t find the cause of the failures, the letter reads.

The agency rapped Greer for another investigation into an out-of-specification result for a lot during sterility testing. Greer attributed the failure to a laboratory error, but other unrelated allergenic extracts failed testing as well, the FDA noted. The investigation did not determine the exact laboratory error.

The FDA called on Greer to correct the deviations quickly. The agency emphasized that failure to do so could result in Greer losing its license to manufacture BLAs.

Greer said that it addressed most of the issues originally raised by the agency and is providing additional information to the FDA explaining its response. The company said it is working closely with regulatory experts to address any remaining observations.

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