Sovereign Warned After Eliminating GMP Requirement, Said OGD Didn’t Need It

Sovereign Pharmaceuticals received an FDA warning letter for failing to test in-process blend samples to ensure uniformity, homogeneity and adequacy of mixing for its acetaminophen and hydrocodone bitartrate tablets.

The company told the FDA that the Office of Generic Drugs did not require routine blend uniformity testing as a condition of approval, so it eliminated the in-process blend uniformity testing. But “in-process testing of the blend to demonstrate adequacy of mixing and homogeneity is a cGMP requirement,” according to the recently posted warning letter.

A Jan. 18 to Feb. 2, 2012, inspection of the Fort Worth, Texas, facility also found investigation failures. For example, Sovereign’s investigation of the out-of-specification percent yield for one lot of Liquibid PD-R tablets is inadequate, the letter states.

The company found a low yield was due to its rejection of product contaminated with particulate matter. It attributed the contamination to a malfunctioning mixer but did not look into the possible contamination of other lots manufactured with the same mixer. Without justification, Sovereign stated this was an isolated incident, according to the letter. This is a repeat observation from an October 2004 inspection.

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