The complaints began rolling in after Cipla Limited began commercially manufacturing albuterol rescue inhalers for the US market in April 2020 at its plant in Pithampur, India, according to a 17 November FDA warning letter that skewered the Indian pharmaceutical company’s response to them.
How The US FDA Responded To Cipla’s Dismissal Of Rescue Inhaler Complaints
Could Cipla dissuade the FDA from issuing a warning letter by defending the dismissal of thousands of complaints from asthma sufferers about jammed albuterol inhalers that came to light during a site inspection? The agency’s answer came in a warning letter.
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