'Does not provide assurance'

Phrase: "Does not provide assurance"

In March, Bristol-Myers Squibb got a visit from FDA inspectors in Puerto Rico. The drugmaker got a letter that included an observation that FDA inspectors saw ongoing problems with operators failing to follow procedures. The agency instructs the company to ensure that personnel "employ strict discipline as they comply with adequate and appropriate procedures." Furthermore, in a response, BMS says that a log book will be used to document supervisory observation of the aseptic filling process. However, the FDA writes that use of a log book "does not provide assurance of adequate supervision."to document supervisory observation of the aseptic filling process does not provide assurance of adequate supervision. Please provide a plan that evaluates your training program, specifically the program's effectiveness and your assurances of personnel compliance to aseptic processes prior to certification to work in an aseptic area."

CP Pharmaceuticals also saw the phrase "does not provide assurance" in an Oct. 29 warning letter related to its aseptic filling process. "Your control systems and operations do not provide assurance that the production rooms and equipment maintain aseptic conditions. Additionally, your environmental monitoring practices do not include adequate routine examination of the facilities and equipment to ensure that possible contaminants can be detected." 

Last summer, FDA inspectors knocked on Apotex's door in Toronto, Canada--and the subsequent news wasn't good.  As we reported this spring, contaminated drug ingredients, the return of defective material to inventory, and the re-release of failed material prior to sufficient reprocessing and testing are among the quality-control shortcomings at the Toronto facility.

Included in the FDA's missive is the phrase "does not provide assurance." In one part of the letter, the regulator states an investigation begun Oct. 2, 2009 for certain diltiazem capsules indicated that a powder residue was present on some of the units used in the facility. A certain type of piping came in contact with the product. "Your investigation is inadequate because it does not provide assurance that the powder particles did not contaminate the product. Your actions did not include a global approach of corrective actions."

'Does not provide assurance'
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