FDA blasts In­di­an man­u­fac­tur­er's MD site for un­clean con­di­tions in Form 483 let­ter

For the first time in more than a year, the FDA has post­ed a Form 483, and this time a Rockville, MD plant of In­di­an man­u­fac­tur­er Ju­bi­lant Gener­ics got the bad news.

In March, in­spec­tors no­ticed left­over residue on a com­pres­sion ma­chine used for three dif­fer­ent tablet batch­es, fail­ing to pre­vent po­ten­tial con­t­a­m­i­na­tion. Drug residue and par­ti­cles were found in the drain pipe and on the walls, and rust was found on the port of a ma­chine used for six dif­fer­ent drugs dis­trib­uted in the US.

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