New Delhi : The Hyderabad-based Sri Krishna Pharmaceuticals has been warned by US health regulator for violations of good manufacturing practices at its facility, including data integrity issues. In a warning letter to the drug firm’s Chairman V V Subba Reddy, the US Food and Drug Administration (USFDA) said its investigator “identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals…”.
One of the violations was that the company failed to ensure laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards, the warning letter said.
Listing out specific issues, the letter stated: “Our investigator discovered that your firm was destroying original batch records and backdating revised replacement pages.”
