Drug factory · FDA FEI 1000266995

Hisamitsu Pharmaceutical Co., Inc.

408, Tashirodaikammachi, Tosu, 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.

Jul 4, 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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components, drug product containers, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.

Sep 15, 2017 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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over humidity is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

Apr 11, 2014 inspection

• 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.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs.
• Signature and checking of records -- 2 persons 21 CFR 211.186(a)
  The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
• Identification of each component or in-process material 21 CFR 211.188(b)(3)
  Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
• 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.

Feb 17, 2012 inspection

• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not derived from previous acceptable process average and process variability estimates where possible.
• Sampling/testing of labeling/packaging materials 21 CFR 211.122(a)
  Labeling and packaging materials are not representatively sampled upon receipt and before use in packaging and labeling of a drug product.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed and documented at the time of performance.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• 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.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• 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.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.

Registered with FDA for: manufacture.