FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A man­u­fac­tur­ing fa­cil­i­ty be­long­ing to the Nether­lands-based API pro­duc­er Fa­gron Group has en­tered the FDA’s crosshairs af­ter an em­ploy­ee de­stroyed a clean­ing log, among oth­er vi­o­la­tions.

One of its plants in Saint Paul, MN re­ceived a warn­ing let­ter on June 14, fol­low­ing an in­spec­tion last No­vem­ber that un­cov­ered cross-con­t­a­m­i­na­tion con­cerns.

“In your re­sponse, you pro­vid­ed a fol­low-up clean­ing val­i­da­tion re­port in which you on­ly as­sessed the car­ry­over of niacin swab sam­ples but not prog­es­terone, which was in­clud­ed in your ini­tial clean­ing val­i­da­tion,” FDA says in the let­ter. “The lack of prog­es­terone (b)(4) [com­mer­cial­ly con­fi­den­tial in­for­ma­tion] is con­cern­ing con­sid­er­ing the fail­ing residue re­sults you pro­vid­ed to in­ves­ti­ga­tors would yield un­ac­cept­able lev­els of prog­es­terone cross-con­t­a­m­i­na­tion.”

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