The QMN Weekly Bulletin

Two API Makers Come Under Fire for Deficient Procedural Systems

Aug. 26, 2016

Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities.

Drugmakers Delavau and Faencal Tartaric both were cited for deficiencies in setting and following proper manufacturing procedures to ensure batch conformity.

Delavau’s Philadelphia-based facility landed a 10-observation 483 for its deficiencies, six of which were repeats of findings from an earlier inspection in 2013.

The 483 cites a lack of recordkeeping on stability characteristics, storage conditions and retesting dates.

Delavau had promised to document accelerated studies on three lots within a month but failed to conduct proper tests on two of those lots, the FDA said. Additionally, the company failed to correct or document previously cited failings from the 2013 inspection.

The inspection also found no documentation on quality-related complaints, specifically the company’s failure to examine and retain samples as part of its foreign material complaint handling. Despite approval from quality personnel, the company neglected to evaluate the potential impact of proposed changes to a specific active pharmaceutical ingredient.

The last observation states that the company did not maintain an equipment cleaning logbook or laboratory records of testing results after cleaning equipment.

Faencal Tartaric 483

Faencal Tartaric was issued an 11-observation 483 over numerous procedural shortcomings.

During an inspection of the company’s plant in Fresno, Calif., the company was cited for inappropriate cleaning and equipment maintenance, as well as improper validation and log-in processes that could expose products to contamination.

The 483 specifies a lack of recordkeeping on stability characteristics, specification standards, test procedures and laboratory records on products and instruments used. Furthermore, the batch production and control records failed to include information on lab control results, sampling and labeling of specimen.

The 483 also points out issues with the quality control unit responsible for establishing SOPs, noting that the group had not drafted, reviewed or approved procedures in at least three instances.

Lastly, the investigator observed employees sharing passwords, citing laboratory analysts for failing to use unique identifiers while performing tests.

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