FDA warns Cipla's al­buterol in­haler plant af­ter thou­sands of com­plaints

The FDA on Tues­day raised se­ri­ous ques­tions about In­di­an al­buterol in­haler man­u­fac­tur­er Cipla in a new warn­ing let­ter af­ter the com­pa­ny re­ceived thou­sands of com­plaints of de­fec­tive prod­ucts in re­cent months.

Cipla has yet to cor­rect the is­sues, which the FDA said “showed a marked and ad­verse trend of crit­i­cal drug de­liv­ery fail­ures.”

The man­u­fac­tur­er re­ceived about 3,000 com­plaints from the start of com­mer­cial man­u­fac­tur­ing in April 2020 to De­cem­ber 2022 about its al­buterol sul­fate in­hala­tion aerosol prod­uct, ac­cord­ing to the FDA. But in Jan­u­ary 2021, the com­pa­ny con­clud­ed that there was no risk to prod­uct qual­i­ty and pa­tient safe­ty based on a risk as­sess­ment.

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