Drug factory · FDA FEI 3005035920

Caplin Steriles Limited

SURVEY No.895 & 897. GURUVARAJAKANDIGAI, SIRUPUZHALPETTAI (POST), THIRUVALLUR (DISTRICT), Gummidipoondi, India

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jun 14, 2019 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.

Registered with FDA for: analysis; manufacture; pack.