Drug factory · FDA FEI 3010165760

Invaderm Corporation

25 Worlds Fair Drive, Somerset, NJ, 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 26, 2019 inspection

• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established standards and laboratory control mechanisms are not followed.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
• Testing and standardization of standards et. al. 21 CFR 211.194(c)
  Laboratory records do not include complete records of any testing and standardization of laboratory reference standards.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Backup data not assured as exact and complete 21 CFR 211.68(b)
  Backup data is not assured as complete through keeping hard copy or alternate systems.

Jun 15, 2017 inspection

• 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.
• Retention time of reserve samples, in general 21 CFR 211.170(b)(1)
  You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
• Records not made readily available to FDA 21 CFR 211.180(c)
  Records associated with drug product components, containers, closures, labeling, control and distribution and within the retention period for such records, were not made readily available for authorized inspection.
• Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
  Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.

May 30, 2017 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.
• 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.
• Records not made readily available to FDA 21 CFR 211.180(c)
  Records associated with drug product components and control and within the retention period for such records, were not made readily available for authorized inspection.
• 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.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing and holding of a drug product lack the training and experience 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 and of adequate size to facilitate operations for its intended use.
• 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.
• 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.

Registered with FDA for: manufacture.