The FDA issued Form 483s to two international API makers, citing recordkeeping failures and incomplete labeling.
A January 2016 inspection of Cosma’s facility in Ciserano, Italy turned up inadequate maintenance of testing data.
The facility allowed deletion or overwriting of data for several of its chromatography and spectroscopy systems, and it lacked procedures for reviewing audit trails. The FDA also faulted Cosma for failing to keep chromatographic data earlier than 2011 and for its practice of destroying raw equipment calibration data.
Investigators also found water used in manufacturing was not monitored or controlled for objectionable organisms, and the specifications for two of its non-sterile APIs did “not contain specifications for microbiological and endotoxin analysis.”
In addition, Cosma’s training files lacked practical details, according to the 483, and investigators also found many cases wherein working copies of cleaning batch records deviated from master records. In addition, API product labels lacked required re-test dates or manufacturers’ names and addresses.
Following an inspection of the SRL’s Germany facility in January 2016, FDA investigators wrote that the company did not properly investigate or classify complaints. Moreover, the company did not set timeframes for complaint investigations or ensure that those investigations covered product batches.
Investigators identified issues with record-keeping in numerous areas. For example, SRL not only failed to adequately record the production process for manufacture of certain ingredients, but it also omitted statements of theoretical yield and minimum, maximum, and yield percentages from its master production and control records.
Liability risk isn’t limited to illegal activities like paying kickbacks or bribing officials. Off-label promotion, adverse event reporting and even basic GMP issues can trigger an FCA action. The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen.