Drug factory · FDA FEI 3002807242

Istituto Biochimico Italiano Giovanni Lorenzini

Via Fossignano 2, Aprilia, Italy

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 21, 2024 inspection

• Timely submission 21 CFR 314.81(b)(2)
  An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.

Jul 17, 2018 inspection

• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
• 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 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.
• Supervisor Training/Education/Experience 21 CFR 211.25(b)
  Individuals responsible for supervising the processing of a drug product lack the training 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.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Jul 4, 2017 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.
• Testing in same container - closure system 21 CFR 211.166(a)(4)
  The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.

Mar 3, 2015 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• 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 components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
• Dedicated equipment: records part of batch record 21 CFR 211.182
  The records of cleaning, maintenance, and use for dedicated equipment are not part of the batch record.
• 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, control, instructions, sampling, testing, procedures, specifications, special notations, and precautions.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
• Retest of approved components/containers/closures 21 CFR 211.87
  Approved components, drug product containers, and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.

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