Drug factory · FDA FEI 3002949099

Dr. Reddy's Laboratories Limited

Survey No. 41, 42 part, 45 part & 46 part, Bachupally Village and Mandal, Medchal-Malkajgiri District, , Medchal-Malkajgiri, 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.

Oct 27, 2023 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Acceptance of drug products 21 CFR 211.160(b)(3)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
• Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
  The use of instruments, apparatus and recording devices not meeting established specifications was observed.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
• 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.
• 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.
• 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.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Feb 8, 2019 inspection

• In process materials - conformance to written specs 21 CFR 211.160(b)(2)
  Laboratory controls do not include a determination of conformance to written specifications for in-process materials.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
  Master production and control records lack sampling and testing procedures.
• 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.
• Approve or reject components, products 21 CFR 211.22(a)
  The quality control unit lacks the responsibility and authority to reject all drug products.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
• Adequate lab facilities not available 21 CFR 211.22(b)
  Adequate lab facilities for testing and approval or rejection of in-process materials and drug products are not available to the quality control unit.
• 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.
• Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
  The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug products and to prevent contamination.
• Drains--Size, Back-siphonage Prevention 21 CFR 211.48(b)
  Drains are not provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Apr 28, 2017 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
• 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.
• Complete Test Data 21 CFR 211.194(a)(4)
  Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to fully investigate errors that have occurred.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the education, training and experience required to perform their assigned functions.
• Supervisor Training/Education/Experience 21 CFR 211.25(b)
  Individuals responsible for supervising the manufacture and processing of a drug product lack the education, training and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Registered with FDA for: analysis; manufacture; pack.