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FDA Returns to Cipla Pithampur;7 Observations Renew GMP Remediation Pressure

USFDA issued a Form 483 with seven inspectional observations to Cipla Limited’s Pithampur manufacturing facility in Madhya Pradesh after a follow-up cGMP inspection from August 17 to August 25, 2026. The outcome renews scrutiny of a site that received eight
  • News
FDA Returns to Cipla Pithampur;7 Observations Renew GMP Remediation Pressure

Caplin Steriles Gets 10 FDA Observations; Its Response Now Takes Center Stage

The U.S. Food and Drug Administration completed an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility in Gummidipoondi, Tamil Nadu, on August 21, 2026. The inspection ended with a Form 483 containing 10 observations. Caplin Point Laboratories said
  • News
Caplin Steriles Gets 10 FDA Observations; Its Response Now Takes Center Stage

Sterile Area Maintenance in 2026: Inspection Readiness

Sterile Area Maintenance in 2026 examines how cleanroom control failures impact GMP inspection outcomes. This article explains key contamination risks, regulatory expectations, and maintenance practices that influence sterile manufacturing compliance and inspection readiness in pharmaceutical environments.
  • Blog, Quality Management System
Process flow diagram showing how cleanroom maintenance failures escalate into contamination risk during sterile manufacturing GMP inspections