Drug factory · FDA FEI 3003656524

Otsuka Pharmaceutical Co Ltd

Matsudani, Itano-cho, Itano-gun, Japan

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.

Feb 15, 2019 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures and laboratory control mechanisms are not followed.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Jul 22, 2016 inspection

• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations. Electronic records are used, but they do not meet systems validation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
• 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 systems validation, retention and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Returned drug procedures in writing and followed 21 CFR 211.204
  Procedures describing the holding and testing of returned drug products are not in writing.
• 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. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.

Mar 20, 2014 inspection

• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Rotation of components/containers/closures 21 CFR 211.86
  There is a lack of rotation so that the oldest approved stock of components is used first.

Oct 21, 2011 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.
• Control procedures fail to include the following 21 CFR 211.110(a)
  Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments is not done at suitable intervals .
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include specific test methods.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Registered with FDA for: analysis; manufacture.