Cephazone Pharma has received a closeout letter, resolving a 2011 warning letter that cited good manufacturing practice (GMP) violations and tardy responses to FDA inspection findings.
The agency will continue to assess its Cephazone's GMP compliance corrections in future inspections, the recently posted closeout letter states. It follows an April 25, 2011, warning letter citing various observations related to the company's laboratory testing practices and in-house procedures. Cephazone makes ceftriaxone for injection, USP.
The FDA questioned Cephazone's sterility testing of its antibiotic product, noting validation lapses in its written procedures for preventing microbiological contamination.
Agency investigators also criticized the Pomona, Calif.-based company's practices surrounding its storage of microbial isolates and of its computer systems security controls.
Cephazone sent the FDA a response to the inspection on Sept. 2, 2010, but it lacked “sufficient corrective actions,” the agency said. The company then sent the FDA a series of follow-up written responses, but because they were received more than 15 business days after the FDA Form 483 was issued, they were not taken into consideration, the agency said at the time. — June 2012
Cephazone Pharma Gets Closeout to 2011 FDA Warning on GMP Violations:
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