Drug factory · FDA FEI 3011905047

Eugia Sez Private Limited

Sy No: 408 to 412, 418 to 435, 437 to 445, 452 to 459, TSIIC, SEZ, Plot No: S-5/B, S-6 & S-7, S-13/B and S-14/B, Polepally Village, Jadcherla Mandal, Mahabubnagar, 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.

Mar 1, 2019 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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity and specificity of test methods have not been documented.
• Record information required 21 CFR 211.184(a)
  The records for components do not include the identity and quantity of each shipment of each lot, name of the supplier, supplier's lot number and date of receipt.
• 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.
• 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 training required to perform their assigned functions.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• 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.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the sampling and testing of components.

May 4, 2018 inspection

• 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.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Registered with FDA for: analysis; manufacture; pack.