A Cadila Healthcare manufacturing plant in Ahmedabad, India, is the recent recipient of an FDA warning letter, largely for microbiological violations. Pankaj Patel, chairman at Cadila parent Zydus Group, was sent the missive on June 21, following a late January inspection of the plant.
FDA inspectors discovered that microbiologists in two instances identified sampling plates as "nil" when in fact each had one colony forming unit. The 1-CFU load is enough to trigger an investigation per company procedures. So the nil findings would have precluded investigations, possibly allowing CFU growth to continue.
In a separate incident, a microbiologist incorrectly reported a microorganism as typical flora. But the FDA inspector found it to be atypical due to its absence from a company reference used in microorganism identification.
Cadila responded that it had investigated the incident and retrained the microbiologists. It said also that two microbiologists would observe counts for three months to "rule out any possibility of erroneous reporting." But the FDA considered the plan inadequate and incapable of improving on the current method for reading plates and recording data.
"You are responsible for the accuracy and integrity of the data generated by your firm. We are concerned that trained microbiologists were unable to identify microbial growth on environmental monitoring plates," the letter says. And then the regulator sends the drugmaker back to the drawing board. "Provide a more comprehensive corrective action plan to ensure the integrity of all data used to assess the quality and purity of all drugs manufactured at your facility."
- here's Warning Letter 320-11-015
Special Report: Frightening Phrases: Warning letter language to watch