Indian API Maker Warned for Validation, Batch Investigation Failures

August 11, 2015

Sipra Labs landed an FDA warning letter for major cGMP violations, including failure to investigate batch discrepancies and failure to establish and document testing methods.

During a Feb. 24 to March 1, 2014 inspection of the firm’s Hyderabad, India, facility, investigators found that written procedures didn’t address the need to investigate unexpected events and out-of-trend batch results. For example, an employee noticed an anomaly with the carbon, hydrogen, nitrogen, oxygen and sulfur analysis of a sample, but repeated the analysis for three other samples. No one documented whether the event was reviewed or reported to Sipra’s customers, the July 23 warning letter says.

In addition, Sipra had not validated 10 of the 14 analytical methods it uses to test products and had no SOPs for validation procedures. The company also failed to conduct robustness testing.

The FDA rejected Sipra’s response that it performed testing according to the terms of quality agreements with clients, saying manufacturers of finished drugs need all test results to assess whether an API should be used in a product.  

The agency also wants Sipra to provide customers with out-of-specification reports and seek feedback on the suitability of its testing methods. The firm’s response to the warning letter should include an example of a drug manufacturing quality agreement.

The warning letter is the latest in a slew of warnings and Form 483s issued to foreign API makers related to cGMPs and data integrity issues.

Sipra Labs did not respond to a request for comment by press time. View the warning letter at www.fdanews.com/08-06-15-SipraLabsWarning.pdf. — Kellen Owings