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FDA Hits Guardian Drug for Lack of Quality Controls, Secure Data

April 20, 2017

The FDA cited Guardian Drug Company over quality and data storage issues.

Following a late 2016 inspection of the drug makers Dayton, New Jersey facility, the agency issued a Form 483 noting the facility lacked adequate controls to monitor or prevent product contamination from metal surfaces during production.

The agency also faulted the facility’s lack of appropriate controls for laboratory reagents and reference standards. One product, labeled as requiring refrigeration, was stored at ambient temperatures. Other components were observed to have assigned 10-year expiration dates although supplier guidelines called for a shelf life of five years after opening, in cases where expiration dates were not specifically stated.

The inspection further found the facility did not routinely back up electronic data to safeguard against deletion or alteration. Some data was stored on a local PC and was not being backed up to a secondary location.

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