Drug factory · FDA FEI 2618677

Baxter Healthcare Corporation

250 Road 144, Jayuya, PR, 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.

Dec 21, 2018 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.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity and reproducibility of test methods have not been established.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Sample size - test intervals 21 CFR 211.166(a)(1)
  The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability.
• 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 any unexplained discrepancy whether or not the batch has been already distributed.
• Laboratory equipment calibration records 21 CFR 211.194(d)
  Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not 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.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the cleaning of equipment.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the sampling and testing of components.

May 1, 2015 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.
• 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 not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
• Protection from external factors 21 CFR 211.94(b)
  Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
• 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.

Feb 11, 2014 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of drug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
• 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 19, 2013 inspection

• 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.
• 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.

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