Drug factory · FDA FEI 3002647489

Gland Pharma Limited

Survey No. 143 - 148, 150 & 151, Near Gandimaisamma Cross Roads, D. P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal - Malkajgiri District, Hyderabad, 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.

Jul 25, 2024 inspection

• Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
  All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
• 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.

Jul 14, 2023 inspection

• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

May 16, 2019 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Product flow through building is inadequate 21 CFR 211.42(b)
  The flow of components, drug product containers and closures though the building is not designed to prevent contamination.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Written procedures lacking for use of pesticides etc. 21 CFR 211.56(c)
  Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment and components.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.
• Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
  Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.

Sep 7, 2012 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• 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.
• Drug products-sampling procedures/specifications 21 CFR 211.160(b)(3)
  Laboratory controls do not include a determination of conformance to appropriate specifications for drug products.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the processing and packing of a drug product lack the training required to perform their assigned functions.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

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