Drug factory · FDA FEI 1000135190

Carlsbad Technology, Inc.

5922 FARNSWORTH CT, Carlsbad, CA, 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.

Jun 30, 2026 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.
• 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.
• 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.
• 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.
• 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.

Nov 5, 2021 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.

Oct 25, 2019 inspection

• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.
• Written sanitation procedures not followed 21 CFR 211.56(b)
  Written procedures for sanitation are not followed.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the cleaning of equipment.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the cleaning of equipment.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

Nov 4, 2016 inspection

• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not documented at the time of performance. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not documented at the time of performance. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• 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.
• 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.
• Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
  Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
• Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
  Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Registered with FDA for: label; pack.