The FDA has issued a warning letter to a Florida CMO that it says has dirty equipment, poor storage methods and questionable record keeping about whether drugs were effective.
The letter to ANDAPharm in Fort Lauderdale followed an inspection last summer where the issues were uncovered. It lectured the plant operators about a number of failings, two of which were repeats. The FDA suggested it was time for the drugmaker to bring in a consultant that can help it get its act together as far as FDA CGMP responsibilities are concerned.
The letter said the plant’s maintenance program had extended hold times for dirty equipment and did not establish timeframes for replacing parts or cleaning the tablet coating equipment. An exhaust system hadn’t been cleaned since the equipment was installed more than a decade ago.
The FDA was bothered by the fact that inspectors had noted similar issues during visits in both 2012 and 2016.
On top of that, there were questions about the stability of multiple lots of hyoscyamine sulfate, salsalate and phenazopyridine drug products because the plant couldn’t produce information about stability tests storage conditions and length of study. The stability testing issue was also a repeat violation.
Additionally, confirmation that the drugs met strength and purity criteria was put in doubt by the fact that data was recorded on secondary, uncontrolled notebooks or on loose sheets of scratch paper. There also were unmarked boxes of rejected lots of several different drugs in the receiving area, which could lead to rejected lots being released, the FDA noted.
The FDA said that until the problems are corrected, it may withhold approvals for ANDAPharm to produce new drugs for clients from the facility.