Drug factory · FDA FEI 3002749414

G.s. Cosmeceutical Usa, Inc.

131 Pullman Street, Livermore, 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.

Aug 14, 2019 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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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 not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
• Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
  The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, in-process materials and drug products and to prevent contamination.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Dec 3, 2015 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Apr 30, 2012 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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Nov 18, 2010 inspection

• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Cleaning/maintenance records not kept 21 CFR 211.67(c)
  Records are not kept for the maintenance of equipment.

Registered with FDA for: manufacture.