US FDA finds flaws at Sun Pharma’s Guj plant, Top Health News | Latest Health & Healthcare Industry Information and Updates: ET HealthWorld : ETHealthworld.com

A report (FDA form 483) was issued with 10 observations after a recent inspection at the Halol plant, a company filing said on May 10, without disclosing the details. The observations are largely related to “media-fill studies”, improvement in aseptic operations, cleaning & maintenance of equipment, personnel training, and inadequate root cause analysis, analysts said., A report (FDA form 483) was issued with 10 observations after a recent inspection at the Halol plant, a company filing said on May 10, without disclosing the details. The observations are largely related to “media-fill studies”, improvement in aseptic operations, cleaning & maintenance of equipment, personnel training, and inadequate root cause analysis, analysts said., , Read More

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