FDA Warns India API Manufacturer Over Contamination Issues

FDA sent a warning letter to Resonance Laboratories Pvt. Ltd. on Feb. 3, 2017 detailing cGMP deviations found at the company’s Bangalore facility during an inspection the agency carried out from May 2–6, 2016. The letter states the company did not provide enough information to the agency about how the company planned on improving validation procedures.

During the May 2016 inspection, FDA officials found that the company had failed to validate its water system that is used in sterile manufacturing operations. Distilled water used to clean equipment in cleanrooms had an unacceptable level of bioburden.

FDA stated that the company used shared equipment to manufacture API, and data from cleaning verification and validation studies showed ineffective cleaning procedures. The letter stated, “Our investigator discovered that 105 of (b)(4) cleaning verification samples taken between 2015 and the start of our 2016 inspection failed your firm’s specification of no more than (b)(4) ppm for residual drug. After obtaining failing cleaning verification results, you repeated cleaning until you obtained passing verification results. Your firm failed to investigate recurring cleaning procedure ineffectiveness and did not remediate the deficient procedures.” The agency recommends the company obtain a consultant to assist in meeting cGMP standards.