483
Actavis Italy Spa A Socio UnicoActavis Italy Spa A Socio Unico – FDA 483, Mar 15, 2019
Record Details
Actavis Italy S.p.A. in Nerviano, Milan, was inspected and received a Form 483 with six observations primarily concerning manufacturing controls, laboratory procedures, and record-keeping. Issues included inadequate equipment cleaning and design, failure to follow sterile product procedures, and deficiencies in stability testing and laboratory documentation. These observations indicate significant concerns regarding the firm's adherence to good manufacturing practices and quality control.
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ID · 742c91d8-4547-40c4-8285-112e40ea800e
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