Drug factory · FDA FEI 3003065803

Patheon Italia S.p.A.

Viale Gian Battista Stucchi 110, Monza, 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.

May 26, 2023 inspection

• 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, written and followed.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

May 20, 2016 inspection

• Adequate number of batches on stability 21 CFR 211.166(b)
  An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
• 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.

Jun 11, 2013 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established and followed that describe the tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
• 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, written, and followed.
• Labels and labeling stored separately 21 CFR 211.122(d)
  Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.
• 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.
• 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.

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