Drug factory · FDA FEI 1628454

Otsuka ICU Medical LLC

3900 Howard Lane, Austin, TX, United States

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.

Mar 10, 2017 inspection

• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written sampling plans and test procedures are not recorded and justified.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Test methods 21 CFR 211.165(e)
  The sensitivity of test methods have not been established and documented.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• 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. Electronic records are used, but they do not meet systems validation, retention and system access limitation requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

May 23, 2014 inspection

• Verification of component addition 21 CFR 211.101(d)
  Each component is not added to the batch by one person and verified by a second person..
• 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 followed.
• Written calibration procedures 21 CFR 211.160(b)(4)
  Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision, and provisions for remedial action if limits are not met.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
• Individual inventory record 21 CFR 211.184(c)
  Records fail to include an individual inventory record of each reconciliation of the use of each component with sufficient information to allow determination of any associated batch or lot of drug product.
• 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.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written, and followed.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
• Container/Closure Written Test Procedure 21 CFR 211.84(d)(3)
  Drug product container and closure test procedures are deficient in that containers are not tested for conformance in accordance with appropriate written procedures.

Aug 24, 2012 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not followed that describe the in-process controls, tests, 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 and followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.
• 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 to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training and experience required to perform their assigned functions.
• Washing and toilet facilities not provided and accessible 21 CFR 211.52
  Washing and toilet facilities are not easily accessible to working areas.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
• 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.
• Identification of Each Lot in Each Shipment 21 CFR 211.80(d)
  Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for components.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of components for testing or examination.
• Container/Closure Written Test Procedure 21 CFR 211.84(d)(3)
  Drug product container and closure test procedures are deficient in that closures are not tested for conformance in accordance with appropriate written procedures.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

Apr 27, 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the 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.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established quality control criteria are not rejected.
• Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
  Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
• Approve or reject procedures or specs 21 CFR 211.22(c)
  The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• 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.
• 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 drug product containers is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

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