2 US Drug Manufacturers Get FDA Warning Letter For Poor Investigations, Lax Testing and Validation
April 14th, 2022 // 1:42 pm @ jmpickett
Two US drug manufacturers were hit with an FDA warning letter recently for cGMP violations connected to inadequate investigations, sloppy testing of incoming ingredients, as well as improper ethanol screening.
Other FDA issues were related to improper validation of drug manufacturing processes, and both companies were hit with repeat violations.
The FDA warning letters were posted by the agency on April 12 and were sent to Generitech Corp., which makes topical hydroquinone cream, and Yusef Manufacturing Laboratories, which makes sunscreens and hand sanitizers.
FDA investigators noted that Generitech had four cgmp violations, which included not performing identity tests for the API salicylic acid. This is used to make their drug product. Because they did not do proper testing, there wasn’t any scientific evidence that raw materials will conform to the necessary specifications before using them in the making of drug products.
For some of their batches, the assay results for the API salicylic acid was more than expected, but the failures were not investigated by the company.
Generitech also did not validate drug manufacturing processes and did not validate the equipment used to make products. The FDA warning letter stated the company did not do process performance qualification or PPQ studies for several OTC drug products. They also did not have an ongoing program to check process control to make sure there were stable manufacturing processes for stable drug quality.
If the processes are not validated and equipment is not qualified, it’s impossible to show that the drug manufacturing process can make drug products consistently that meet the necessary quality attributes.
The company also did not keep its drug manufacturing and processing equipment clean. That equipment was used to make topical OTC cosmetic and drug products.
FDA stated that not removing active pharmaceutical ingredients from the equipment while cleaning can lead to cross contamination.
The company had similar violations as far back as 2014. The repeated violations show that company oversight of the drug manufacturing processes is inadequate.
Similar cGMP issues were reported by FDA investigators after a 2021 audit of Yusef Manufacturing Laboratories. The company was criticized by FDA for failing to test the API ethanol from its vendor.
FDA told the firm that using ethanol that is intermingled with methanol can cause fatal poisoning instances.
The letter also provided insights on how you should not do a failure investigation. For instance, an assay result that failed was created by testing a single batch of sunscreen. But they didn’t do a complete investigation of the batch that failed. The company only took samples from parts of the three boxes of finished lip balm and got passing results. They didn’t report the average of the results as they should.
The company also was blasted by FDA for not validating drug manufacturing processes that show they are controlled and reproducible. Every part of the drug manufacturing process has to be designed right to assure that raw materials are high quality.
Yusef also was criticized for failing to learn from past errors. Similar FDA violations were noted in 2017.
