Drug factory · FDA FEI 3017140477

LGM Pharma Solutions, LLC

17802 Gillette Avenue, Irvine, 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.

Mar 1, 2024 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Deviations from laboratory control requirements 21 CFR 211.160(a)
  Deviations from written test procedures and laboratory mechanisms are not recorded and justified.
• 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.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Aug 17, 2018 inspection

• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the surveillance, evaluation and reporting to FDA of post marketing adverse drug experiences.
• Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
  You failed to submit a periodic report containing a narrative summary and analysis of the ADE information for the reporting interval in the report, an analysis of the post marketing 15-day Alert reports submitted during the reporting interval, a history of actions taken since the last report because of adverse drug experiences and an index with a line listing of your patient identification code and adverse reaction term(s) for all ICSRs you submitted for the reporting interval.
• Failure to submit electronic format safety report 21 CFR 314.80(g)(1)
  Not all safety report submissions were made in an electronic format.
• Timely submission 21 CFR 314.81(b)(2)
  An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.

Jul 11, 2014 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not reviewed and approved by the quality control unit.
• 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.
• Tentative expiration date 21 CFR 211.166(b)
  Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no stability studies conducted until the tentative expiration date was verified or the appropriate expiration date determined.
• 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.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
• Equipment for Environmental Control 21 CFR 211.46(b)
  Equipment for adequate control over air pressure, humidity, and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components and drug product containers are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
• Destruction of obsolete labels 21 CFR 606.120(b)(2)
  Failure to destroy stocks of obsolete labels.
• Documentation 21 CFR 820.75(a)
  Process validation results have not been approved.

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