FDA Cites Florida Drugmaker for Serious Quality Violations

May 19, 2017

An FDA investigation into serous quality problems at a Florida pharmaceutical company revealed a litany of unsound practices in the manufacture of experimental drugs.

FDA investigators said the quality control unit at Sancilio and Company in Riviera Beach, Fla., neglected to investigate product stability failures for finished drugs currently in clinical trial and registration batches meant to support the company’s NDAs and INDs, according to the Form 483 issued Jan. 20 and recently released by the FDA.

The facility failed to thoroughly review “any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed,” the investigators wrote.

Sancilio develops drugs using proprietary lipid technology as a delivery system for APIs, vitamins and hormones. In addition to on-market generic fluoride and vitamin tablets, Sancilio has clinical trials underway for drugs to combat sickle cell anemia, short bowel syndrome and hypertriglyceridemia.

Ileana Barreto-Pettit, an expert investigator for the FDA, led a team of four — including two FDA chemists — who found the drugmaker had incomplete lab records, no reliable or specific test methods for some clinical drug batches, and a lack of sufficient analytical data to ensure the proper characteristics of the finished drugs.

Samples pulled from drug batches identified as placebo had inexplicable chemical anomalies and the validity of some tests were called into question because proper cleaning procedures and chain of custody protocols were not properly followed, the Form 483 said. Failed assay results were not properly recorded in the certificate of analysis and variations in sample test results were excluded from reports.

Backup data on placebo and drug batches were not secured and therefore considered potentially unreliable, with no hard copy or alternate information systems, including issues with data that investigators noted was “selectively archived.” There was no way to determine if the content of a collection of raw data were additional test files or backup files not properly stored in their designated area.

Written stability testing procedures are not followed, with the company failing to observe set timelines or follow up on inventory discrepancies.

Multiple manufacturing investigations opened in early 2016 had still not been properly investigated, reported or closed as of the inspectors’ visit to the Florida facility Jan. 1-20.

The company received two previous 483s in 2013 and 2015.

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