Drug factory · FDA FEI 3005977675

Ipca Laboratories Limited

Plot No. 65, 99 and 126, Danudyog Industrial Estate, Piparia, Silvassa, 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 23, 2019 inspection

• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures and laboratory mechanisms are not recorded and justified.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

May 28, 2010 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
  The master production and control records are deficient in that they do not include complete manufacturing and instructions.
• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
• Adverse Drug Experience 21 CFR 211.198(a)
  Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
  Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Registered with FDA for: analysis; label; manufacture; pack.