Drug factory · FDA FEI 3011033544

MSN Laboratories Private Limited

FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277& 1319 to 1324, NANDIGAMA (VILLAGE), NANDIGAMA (MANDAL), Rangareddy District, 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.

Nov 15, 2019 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
• 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 and followed.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: analysis; manufacture.