Regulatory Focus™ > News Articles > Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes'

Warning Letter to Allergy Manufacturer Cites Insects, Unapproved 'Custom Mixes'

Posted 06 May 2014 | By Alexander Gaffney, RAC

A new Warning Letter from the US Food and Drug Administration (FDA) to North Carolina-based allergy product manufacturer Greer Laboratories claims that the company failed to manufacture an allergenic extract in the manner described in its approved biologics license application (BLA), among other alleged problems.

The 21 April 2014 Warning Letter-released to the public on 6 May 2014-references a November 2013 inspection by FDA officials at Greer's Lenoir, NC facility.

There, FDA inspectors said that determined that the company was combining "various types and amounts of [its] licensed allergenic extracts to product allergenic 'custom mixtures'" without first having obtained permission from FDA.

While the company wrote in response to the agency that it had manufactured the custom mixes for "some time," FDA responded that each mixture would require a BLA (unless it was made for a specific patient with a valid prescription).

Other Problems: Insects and Bottle Stoppers

Problems escalated from there, FDA contended. Inspectors said they found evidence that Greer had "failed to establish and follow written procedures that describe the in-process controls … in order to monitor the output and to validate the performance of those manufacturing processes." Regulators said they were concerned that the lack of controls could result in a non-uniform product.

In other cases, FDA claimed that Greer's investigations into unexplained discrepancies and batch failures did not meet regulatory requirements under 21 CFR 211.192. For example, FDA cited one instance in which company-conducted bioburden testing found microorganisms "too numerous to count." Despite undergoing sterilization, FDA said it was not convinced that the filters used during the sterilization process were capable of filtering all biological organisms out of the intermediate product. Regulators also said the company had not recorded the event as a deviation, and that the lot was used to manufacture allergenic products.

Other problems were noted by FDA as well. The agency claims Greer had not fully demonstrated that part of its containers used to hold its drugs-the stopper, specifically-were not reactive, additive or absorptive, which can cause the container to leach into the drug product.

Elsewhere, FDA inspectors observed "live insects" in the manufacturing facility's aseptic filling suite, both during and after filling operations. Even after Greer took corrective actions, "live insects continued to be observed in these areas," FDA wrote.

The Warning Letter comes just as Greer has launched its new Oralair sublingual allergy immunotherapy tablet, which it won FDA approval for in April 2014.


Warning Letter to Greer


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe