API manufacturer in China handed warning letter after failing to respond to the regulator’s requests for information

An ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­er in Chi­na re­port­ed­ly lied to the FDA about whether it will con­tin­ue ship­ping prod­ucts in­to the US and did not re­spond to mul­ti­ple re­quests for records, ac­cord­ing to a warn­ing let­ter.

The let­ter, which was sent last week to Cheng­du KeCheng Fine Chem­i­cals Co. Ltd, said the FDA had sent re­quests for records and oth­er in­for­ma­tion a year ago, but they have gone unan­swered. Once an FDA staff mem­ber man­aged to get on the phone with the com­pa­ny in Oc­to­ber, the let­ter al­leges that the re­cip­i­ent “re­fused to pro­vide” their full name or an al­ter­nate email.

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