Drug factory · FDA FEI 3007058211

Excelvision

ZONE INDUSTRIELLE LA LOMBARDIERE 27 RUE DE LA LOMBARDIERE, Annonay, 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.

Jan 22, 2026 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls 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.
• 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.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• 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.
• Floors, walls, ceiling surfaces 21 CFR 211.42(c)(10)(i)
  Aseptic processing areas are deficient in that floors, walls and ceilings are not smooth and/or hard surfaces that are easily cleanable.
• 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 room and equipment to produce aseptic conditions.
• Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
  Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance and inspection of equipment.
• 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.

Feb 10, 2015 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 and written.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
• 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.

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