Contractor Rapped by FDA for Unauthorized Personnel

March 25, 2015

Contract OTC drugmaker Thibiant International allowed unauthorized personnel to access areas of the firm’s buildings and facilities designated as limited access areas, according to an FDA Form 483.

During an October 2014 inspection of the manufacturer’s Chatsworth, Calif., facility, investigators discovered that access to the chemistry, microbiology, and research and development laboratories was not limited to authorized personnel.

Additionally, refrigerator temperature logbooks for the industrial-size refrigerators located in the raw material warehouse were not maintained.

Thibiant International did not return a request for comment by press time.

The Form 483 can be read at www.fdanews.com/03-02-15-Thibiant483.pdf.