Drug factory · FDA FEI 3006549835

Dr.reddy's Laboratories Limited

P1 to P9 & Q1 to Q5, Phase - III, VSEZ, Duvvada, , Visakhapatnam, 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.

May 17, 2024 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.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: analysis; manufacture; pack.