Drug factory · FDA FEI 3004611192

Boiron

2 avenue de l Ouest Lyonnais, Messimy, 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.

Jul 7, 2017 inspection

• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• Homeopathic drugs, assessment of stability 21 CFR 211.166(c)(1)
  There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients and marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use.
• Complete Test Data 21 CFR 211.194(a)(4)
  Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• 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.

Jan 15, 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.
• Component addition checked by 2nd person 21 CFR 211.101(d)
  Each component is not added to a batch by one person and verified by a second person.
• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that conform to appropriate standards of identity, strength, quality and purity.
• Microbiological testing 21 CFR 211.165(b)
  Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
• 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 control, instructions, and procedures.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• 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.
• 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.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

Registered with FDA for: label; manufacture.