Caraco Claims Substantial Compliance With GMPs

Caraco Pharmaceutical Laboratories has shaken up the leadership of its manufacturing and quality control units and says it is now in substantial GMP compliance.

The company received a warning letter from the FDA in October, citing it for repeated GMP violations and questioning Caraco’s expansion plans for its Detroit facilities. In the letter, the FDA said it had serious concerns regarding potential product contamination.

The company has taken corrective action and is working to improve its quality system, Caraco CEO Daniel Movens says in a fiscal 2009 third-quarter earnings statement. “We continue to invest in improved systems, equipment, training and personnel in quality and manufacturing,” Movens adds. “In the last two years, we have added a considerable amount of infrastructure in our quality control laboratories.”
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