FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues
Inadequate responses to findings of potency discrepancies, blending issues and out-of-specification samples during a May 2020 inspection recently landed tablet manufacturer Allay Pharmaceuticals with a scorching FDA warning letter.
In a heavily-redacted version of the Jan 27 letter that was made available this week, the FDA chided the Hialeah, Florida manufacturer for vague and insufficient responses across the board to three major observations discovered during the May 5 to 15, 2020 site inspection. Those observations were communicated through a Form 483 letter, and Allay’s responses to the FDA on June 6 clearly irked the agency.
Most notably, the FDA took issue with the fact that Allay either doesn’t have, or didn’t provide, sufficient data that could explain why the tablet samples of an unnamed drug that were taken during the site inspection last year were below necessary potency standards and varied in what potency they had.
“Your manufacturing failures indicate that you do not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality,” the FDA wrote, later urging the company to consult with a cGMP expert to bring its standards up to code.
While it’s unclear exactly how many drugs the FDA observations are related to, Allay is under contract to produce at least one tablet with a company whose name is also redacted. Regardless of what other terms the two groups agreed to, the FDA made clear to Allay that it is responsible for meeting quality standards, which it hasn’t done or investigated in a thorough manner.
“In the quality agreement with the product owner, you have the primary responsibility for investigating (out-of-specification) results,” the letter reads. “Your investigation into the OOS sample result was inadequate and did not identify (Corrective Action and Preventive Action). Furthermore, an investigation was not performed to ensure that previously released lots met your revised assay specifications. FDA investigators found 13 lots within expiry that exceeded your new assay specification during release or stability testing. These lots should have been identified in your investigation.”
The FDA also highlighted testing errors and discrepancies for active pharmaceutical ingredients, calling out testing results that didn’t match up to those quoted by a new API manufacturer used by Allay. In one instance, the company’s tests on an API lot differed by 7.8% compared to the rate quoted by the ingredient maker, but Allay went ahead with manufacturing its drug anyway, the FDA said.
Allay is now required to provide the FDA with a review of all other products it manufactures, regardless of whether the products were identified in the Form 483 observations, as well as a “comprehensive and independent” assessment essentially of its entire system for addressing deviations from cGMP manufacturing processes.
Allay has 15 business days (Feb. 18) to respond to the FDA’s warning letter. The company did not immediately return a request from Endpoints News seeking comment.