Drug factory · FDA FEI 3002535019

CorePharma, LLC

215 Wood Avenue, Middlesex, 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.

Jun 11, 2012 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include reliable and meaningful test methods.
• 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.
• Returned drug procedures in writing and followed 21 CFR 211.204
  Procedures describing the holding, testing, and reprocessing of returned drug products are not in writing.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed, and held under contract by another company.
• 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 and 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.
• 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.
• 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.

Feb 25, 2011 inspection

• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
• Procedures Written and Followed 21 CFR 211.125(f)
  Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures are not justified.
• 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.
• 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 and fully followed.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Sep 14, 2009 inspection

• Failure by applicant to report ADE 21 CFR 314.80(c)
  Adverse drug experience information has not been reported to FDA.
• Failure to report non-alert ADEs 21 CFR 314.80(c)(2)
  Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report.

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