Drug factory · FDA FEI 3009864167

Gland Pharma Limited

Plot no: 42-52, 54, 55, 64-68, Sy. No. 166, 171, 172 & 177, Phase III, TSIIC, Pashamylaram Village, Patancheru Mandal, Sangareddy 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.

Nov 7, 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 product containers, closures and 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.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.

Feb 23, 2018 inspection

• In-process conformity - examination, sample testing 21 CFR 211.110(b)
  Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
• 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.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.

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