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...".
The violations demonstrated that company's "quality system does not adequately ensure the accuracy and integrity of the data generated at your facility to support safety, effectiveness, and quality of the drug products you manufacture," it added.
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.
USFDA further said: "Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to document same at the time of performance."
Listing out specific issues, the letter stated: "Our investigator discovered that your firm was destroying original batch records and backdating revised replacement pages."
When analysts delete non-conforming test results, the quality unit is presented with incomplete and inaccurate information about the quality of products, it said.
The company failed to exercise appropriate controls over computer or related systems to assure that only authorised personnel institute changes in master production and control records, the letter added.
"None of your explanations justify your failure to maintain complete records, nor do they support your practice of repeating tests or deleting test results," it said.
The health regulator also pulled up Sri Krishna Pharmaceuticals, which acts as a contract manufacturer for various drug products, for not notifying its clients about the CGMP violations.
Warning the company to rectify the violations, USFDA said failure of compliance with CGMP may lead to withholding approval of any new applications or supplements from the firm.
In addition, USDFA said failure to correct these violations may result in continued refusal for "admission of articles" manufactured at the company's Hyderabad plant.
