Indian API maker slammed by US FDA for water and cleaning issues
The warning letter was sent by the US Food and Drug Administration (FDA) earlier this month following an inspection at the Doddaballapur, Bangalore in May last year.
According to the Agency, Resonance Laboratories failed to validate its water system and failed to have adequate cleaning procedures to prevent contamination of its active pharmaceutical ingredients (APIs).
“You failed to demonstrate that distilled water used to clean equipment downstream of the (b)(4) purification steps is suitable for use,” the Agency said. “For example, the distilled water used for cleaning equipment in the (b)(4) cleanrooms, after passing through a (b)(4) micrometer filter, had an unacceptable level of bioburden.”
The Agency noted that while the firm used shared equipment across a number of APIs, data from cleaning verification and validation studies found the cleaning procedures were ineffective.
“For example, 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,” the letter said.
“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.”
According to Resonance Laboratories’ website, six US Drug Master Files (DMF) cite APIs made by the firm: Atropine Sulfate, Buprenorphine Hydrochloride, Clidinium Bromide, Glycopyronium Bromide, Homatropine Methylbromide, and Oxybutynin Chloride/Oxybutynin Hydrochloride.
Based upon the FDA’s findings, the Agency has recommended the firm engages an independent consultant to assist in meeting cGMP requirements.
