Drug factory · FDA FEI 1643045

Curia New Mexico, LLC

4401 Alexander Blvd. NE, Albuquerque, NM, 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 7, 2016 inspection

• 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.
• 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.
• 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.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Jun 5, 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.
• 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.
• 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 test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Jul 17, 2014 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 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 record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure and micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure and micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure and micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

Aug 23, 2013 inspection

• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.

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