In­di­an man­u­fac­tur­er called out for rust and lack­lus­ter records; Span­ish CMO signs 10-year com­mit­ment to make mR­NA vac­cines

An In­dia-based In­di­ana Chem-Port site has been hand­ed a warn­ing let­ter from the FDA, as the agency came down hard on the drug­mak­er for clean­li­ness is­sues that in­clud­ed rust-like residue on equip­ment and tape be­ing used to try to pre­vent con­t­a­m­i­na­tion.

The lack of clean­li­ness showed that the com­pa­ny strug­gled to make APIs that could con­sis­tent­ly meet qual­i­ty stan­dards, the FDA said in the let­ter dat­ed Feb. 2. It al­so failed to val­i­date writ­ten pro­ce­dures for the clean­ing and main­te­nance of equip­ment and fail­ure to es­tab­lish ad­e­quate writ­ten pro­ce­dures.

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