Cephazone Pharma Gets Closeout to 2011 FDA Warning on cGMP Violations
Cephazone Pharma has received a closeout letter, resolving a 2011 warning letter that cited GMP violations and tardy responses to FDA inspection findings.
The closeout letter follows agency warnings related to Cephazone’s laboratory testing practices and in-house procedures. Cephazone makes ceftriaxone for injection, USP.
The FDA questioned Cephazone’s sterility testing of its product, noting validation lapses in its written procedures for preventing microbiological contamination. Agency investigators also criticized the company’s storage practices.
Cephazone sent the FDA a response to the inspection, but it lacked “sufficient corrective actions,” the agency said. Cephazone then sent the FDA a series of follow-up responses, but because they were received more than 15 business days after the Form 483 was issued, they were not taken into consideration, the agency said at the time.
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