Drug factory · FDA FEI 3003157498

Intas Pharmaceuticals Limited

Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi, Sarkhej-Bavla Highway, Taluka -Sanand, Matoda, Ahmedabad, 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.

Aug 2, 2019 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• 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, written and followed.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed and deficiently written or followed.
• Suitability of testing methods verified 21 CFR 211.194(a)(2)
  The suitability of all testing methods is not verified under actual conditions of use.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Air Supply 21 CFR 211.42(c)(10)(iii)
  Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Air recirculation of dust from production areas 21 CFR 211.46(c)
  Air is recirculated to production areas, without adequate measures to control recirculation of dust.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and maintenance.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules and description in sufficient detail of methods, equipment and materials used.

Registered with FDA for: analysis; manufacture; pack.