FDA warning letter smacks Allay Pharma for potency problems, API testing issues

Florida-based drugmaker Allay Pharmaceuticals is in hot water with the FDA after it failed to right the manufacturing wrongs flagged in an inspection last May. 

FDA slapped Allay for failing to set up proper procedures and process controls for tablet manufacturing at its plant in Hialeah, Florida, according to a warning letter posted Feb. 9. Inspectors turned up potency problems, substandard API testing and biologics manufacturing without FDA approval.

At least one of the products involved was made for a contract manufacturing client, the agency said—a fact that yielded a particular scolding. "You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners," the agency said.

Given the range of violations at Allay's facility, the FDA is urging the company to enlist a consultant to help meet manufacturing standards.

Under its own product umbrella, the FDA found tablet samples that weren't potent enough, and one manufacturing lot failed uniformity tests.

This prompted the company to recall two lots of an unnamed drug and destroy another that hadn’t yet hit the market, according to the FDA’s letter.

Investigators took issue with Allay’s blend process in particular, noting that inadequate blending could cause patients to receive too much or too little of a drug, and asked the company to explain the variability in its tablets.

The FDA inspected Allay's Hialeah plant in early May of 2020 and issued a Form 483 rundown of violations. The warning letter comes after Allay's response to that inspection report in June.

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That response fell short, the FDA says, because Allay didn't offer data to show where its manufacturing process is failing, nor has it shown how it will control variability. On top of that, the company failed to provide the agency of a revised validation protocol.

The company wasn't immediately available for comment. 

The FDA in April of 2020 told Allay that agency testing had found out-of-sequence assay results for one tablet lot that it makes under contract.

The company updated its assay specifications for the active ingredient in the tablets, but didn’t fully investigate the poor testing results and failed to detail a corrective action and preventative action plan (CAPA), the FDA said. Meanwhile, the company didn't confirm that previously released lots met its revised standards. 

Allay didn't properly test drug ingredients from a new supplier, the letter states, and validation batches made with those ingredients weren't put into long-term stability testing for almost a year. And the company didn't follow its own stability-testing rules.

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The company also failed to investigate API testing results that didn't match up to test results quoted by the API manufacturer. In one instance, Allay’s tests on a certain API lot charted a difference of 7.8% compared to the API maker’s analysis, but the company stuck to its own results in formulating the finished product anyway.

Overall, Allay failed to properly qualify its new API supplier, the letter says, and still hasn't explained when and how it will requalify the ingredients maker.

Finally, the company is producing tablets classified as biologics without FDA approval or a valid biologics license, the agency said.