When an FDA inspector raised questions about water streaming down some equipment in the fill-and-finish area at Dr. Reddy’s oncology plant in Duvvada, India, a quality control manager repeatedly waved it off as condensation.
When the inspector pointed out it was flowing from a tube that someone had tried to fix with three zip ties and was a problem in a sterile area, the manager finally acquiesced and stopped the filling line.
That is only one example of the slipshod operations the FDA uncovered (PDF) during an August inspection that resulted in an eight-observation, 15-page Form 483 for the facility. It was the second citation in less than a year for the facility, a plant that has created ongoing quality concerns at the FDA over the potential for microbial contamination.
According to the highly redacted citation, the FDA also raised issues about the lack of validation for the sterilization processes as well as lack of visual verifications of cleanliness and other processes. The FDA was also worried that the air flow in the fill area was not being conducted in a way to keep particles from getting into the drugs.
The company last month acknowledged the Form 483, but the FDA only posted it days ago. Dr. Reddy’s has said it planned to address the FDA’s concerns “comprehensively" within the timeline, but that has been an ongoing refrain from India’s second-largest drugmaker.
The oncology plant, which has previously been named in a warning letter, also received a Form 483 last October. But this plant is only one among a number of Dr. Reddy’s facilities where the FDA has found serious shortcomings. This was the fifth Dr. Reddy’s site this year to be given a Form 483 as the drugmaker struggles with quality and repeat violations.
Dr. Reddy’s manufacturing issues also appear to be affecting the company’s ability to launch drugs. Although it did not explicitly say it was tied to manufacturing problems, the drugmaker last month received a Complete Response Letter for two potentially very lucrative products, generic versions of Teva’s Copaxone and Merck’s birth control device NuvaRing.