Drug factory · FDA FEI 3000234005

Fareva Amboise

Zone Industrielle, 29 route des industries, Poce-sur-Cisse, France

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.

Sep 16, 2025 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.
• 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.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• Written procedures followed 21 CFR 211.186(a)
  Procedures for the preparation of master production and control records are not described in a written procedure.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized 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.

Mar 18, 2014 inspection

• Control procedures fail to include the following 21 CFR 211.110(a)
  Control procedures fail to include clarity, completeness or pH of solutions.
• 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.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established standards and quality control criteria are not rejected.
• Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
  Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
• Determination not to conduct investigation of complaint 21 CFR 211.198(b)(3)
  The written record did not include the reason an investigation was found not to be necessary when an investigation into the failure of a batch or any of its components to meet specifications was not conducted.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include assignment of responsibility and description in sufficient detail of methods, equipment and materials used.
• Microbiological Contamination Exam 21 CFR 211.84(d)(6)
  Each lot of a closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.

Sep 20, 2011 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not consistent with drug product final specifications and determined by the application of suitable statistical procedures where appropriate.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established standards and quality control criteria are not rejected.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

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