FDA notes only two observations in 3M inspection.(HUMAN DRUGS)

3M, Northridge, CA Los Angeles District

An FDA inspection team issued a 483 with just two observations for 3M's facility for manufacture of prescription tablets, aerosols and transdermal patches.

FDAers Uttaniti Limchumroon, Kelvin Sanders and Sarah Hassas cited the company for failure to maintain proper records on the cleaning of equipment, noting that 3M's clean check log did not have documentation showing specific steps required.

The investigators also observed that the firm's Master records for nitroglycerin "did not have a theoretical yield statement or a theoretical yield maximum percentage beyond which investigation is required," the report stated.

In their discussion with management at the close of the inspection conducted Jan. 11-20, 2006, the team also noted that 3M did not always fully document corrective action performed as part of investigation. "Some documentation did not include corrections performed on equipment affected," the FDAers wrote. The inspectors said the firm needed to document who performed the changes, what was changed and the equipment used.

In addition, the inspection revealed that all investigation-related documents were not kept in one file, such as a CAPA or change control file. The team stated that without all documentation being maintained in a single place, "there is no assurance that the final reviewer will have all of the related documents attached to the investigation to make a proper assessment of the system affected."

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