FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility

FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility

July 5th, 2022 // 6:49 pm @

After it stopped sending FDA warning letters to 503B outsourcing facilities in 2021, FDA gave a warning letter in June 2022 to Hybrid Pharma after an FDA inspection that concluded in late 2021. It looks like FDA is returning aggressively to the 483 and warning letter trend, as the same pharmaceutical company got another warning letter in 2018.

The November 2018 letter was mostly about failures to fulfill the Section 503B conditions, the newest warning letter is more about CGMP compliance.

The 2018 letter explained Hybrid’s inadequacies in adhering to the 503B provisions, such as compounding drugs that were not authorized for exemptions under the rule; lack of sufficient labeling; not meeting drug product reporting requirements, and lack of adverse event reporting.

Hybrid Pharma seems to have corrected these flaws before the most recent FDA audit. The only 503B problem noted in the 2022 warning letter was not submitting a full report to FDA that pinpointed all of the drug products compounded by the plant during the previous 180 days.

The other warning letter observations were about the company’s failure to follow cGMPs, which mostly follow recent trends noted in FDA cGMP observations in warning letters and 483s that are issued to 503B outsourcing companies.

Some of the significant CGMP issues mentioned in the warning letter included not investigating batch failures and any unexplained discrepancies whether the batch was distributed or not; not establishing the sensitivity, accuracy, reproducibility and specificity of drug test methods; failing to set up a system to monitor environmental conditions for aseptic processing.

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