FDA inspectors have cited data manipulation and falsification at any number of manufacturing facilities in India, but a new warning letter for three Ipca Laboratories plants shows that it was rampant at that company, enforced by senior managers in the quality-control unit to keep product supply flowing.
Ipca recently acknowledged getting the warning letter for its API plant in Ratlam and formulations plants in Pithampur in Madhya Pradesh and Piparia in Silvassa. Ipca had stopped shipping products from the plants after the 2014 inspections which led to the facilities being placed on the FDA import alert list. The company says it has been making progress in getting its house in order but the FDA warning, sent last month and posted on its website today, shows the Indian company has a lot to overcome.
According to the warning letter, employees regularly deleted failed testing data from computers and overwrote them with data that indicated APIs and products met standards.
One Ipca employee told inspectors, "if we find a failure, we set back the date/time setting and re-integrate to achieve passing results." The analyst told inspectors that deleting, overwriting, changing integration parameters, and altering PC date and time settings were done for raw materials, in-process testing, and finished API drugs, the letter says.
And it was not as if managers didn't know. The FDA says that an anonymous email to the quality unit in August 2013 informed quality managers about the data falsification, but that "senior management failed to take sufficient corrective action and prevent the recurrence of these problems." One manager acknowledged ordering an employee to backdate records.
Data falsification was also found in the microbiology labs where records were routinely changed and backdated. Inspectors discovered that 43 of 117 sample plates were missing from an incubator at one plant without any reasonable explanation. At another plant, the labs had documented plates with microbial growth for Staphylococcus aureus but never investigated the cause or implications for product quality.
Ipca has claimed several times that it is working to get all of its problems behind it. In its public filing about the warning letter, the drugmaker said that it was working with outside consultants to resolve all of its problems as quickly as possible and was committed to the "highest quality in manufacturing."
- here's the warning letter