Cambrex's missing records mishap
Lab control records for the analysis of APIs that were unavailable for the FDA's March 2009 inspection of a Cambrex Profarmaco facility in Milan, Italy, raised the regulator's eyebrows (WL: 320- 09-10). The missing records prevented investigators from confirming data submitted to support a drug application.
The company responded that the study was quite old and the retrieval of raw data was more difficult than anticipated. In addition, quality unit personnel told investigators that the raw data were lost during a computer software upgrade. "We have serious concerns about your firm's implementation of changes to your computerized systems," according to the warning letter. "It is your responsibility to provide the means of ensuring data protection (e.g., back-up system) for your computerized systems to prevent the permanent loss of records."
The company also explained the "raw data were difficult to collect and found partially incomplete because [they had been] recorded in different notebooks as the study was done by more analysts after a reorganization of the laboratory."
The FDA remained steadfast: "Recording of raw data in different notebooks by your analysts and the reorganization of your laboratory should have no effect on the traceability and accountability of your raw data."
Cambrex then maintained that it was unable to find the printouts from the instrument used to gather the raw data and that the missing printouts "were probably aborted instrument runs that were not filed with the complete sequence of analysis."
"The omission of the raw data (i.e., alleged aborted runs) from a complete sequence of analyses raises serious concerns regarding the integrity and reliability of your analytical results," the warning letter says.