Cloudy water got Indian drugmaker Dr. Reddy’s Laboratories in hot water with the FDA, a Form 483 inspection report shows.
An FDA inspector said the water bath in a laboratory dissolution tester was not clear, and there also was whitish material floating in the water.
The company’s quality control supervisor nevertheless approved the tester for analysis and a lab worker recorded the water as clear, both indications of inadequate training, the report said.
The dissolution tester was involved in another citation, as lab workers did not calibrate the instrument after maintenance, as called for in the company’s written procedures – and a supervisor then contradicted those procedures and wrote that they were not necessary to follow, the report said.
The FDA previously identified good management practice shortfalls at multiple Dr. Reddy’s sites, issuing a Form 483 report earlier this year and a warning letter in 2015.