Emer­gent nets it­self more trou­ble as it re­ceives a warn­ing let­ter from the FDA

Emer­gent BioSo­lu­tions is fac­ing a fresh set of man­u­fac­tur­ing trou­bles as the FDA is­sued a warn­ing to the com­pa­ny re­gard­ing its Bal­ti­more site.

Emer­gent re­vealed in an SEC fil­ing on Fri­day that the US reg­u­la­tor is­sued a warn­ing let­ter on Aug. 10, flag­ging two ar­eas of con­cern at the com­pa­ny’s Cam­den man­u­fac­tur­ing fa­cil­i­ty in Bal­ti­more.

The FDA let­ter point­ed to de­fi­cien­cies in the Emer­gent plant’s sys­tems for clean­ing and main­te­nance of equip­ment to pre­vent con­t­a­m­i­na­tion of drug prod­ucts, specif­i­cal­ly re­lat­ed to par­tic­u­lates from the met­al trays. It al­so not­ed de­fi­cien­cies in process­es and prac­tices sur­round­ing asep­tic pro­cess­ing.

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