FDA EIR - 1H[JHQ 3KDUPD ,QF - December 03, 2018

An unannounced FDA Drug Process Inspection of Nexgen Pharma, Inc., a contract manufacturer of over-the-counter (OTC) and homeopathic finished drug products located in Rosenberg, TX, was conducted from November 26 to December 3, 2018. The inspection, performed under regulatory framework CP 7356.002, assessed various systems including Quality, Materials, Laboratory Control, and Facility & Equipment.

While the inspection was classified as "No Action Indicated" (NAI) and no FDA Form 483 (Inspectional Observations) was issued, two significant observations were discussed. First, a sterilizer in the microbial testing laboratory had a door gasket with black residue that had not been replaced since its 2004 installation, despite manufacturer recommendations for periodic replacement. The firm's pre-use inspection procedure for this unit also lacked specific guidance for gasket assessment. Second, electronic laboratory test data lacked verification after being backed up to the IT server, though it was verified beforehand.

Nexgen Pharma, Inc. management acknowledged these concerns and committed to addressing them. Required actions include replacing the sterilizer’s door gasket as a preventive measure and reviewing their laboratory data verification process to ensure data integrity after backup. The FDA communicated that the final report would be reviewed, and potential violations of the FD&C Act could lead to legal sanctions if these conditions are not corrected.