Drug factory · FDA FEI 2016148

International Medication Systems, Ltd.

1886 Santa Anita Ave., South El Monte, 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.

Dec 19, 2025 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Laboratory equipment calibration records 21 CFR 211.194(d)
  Laboratory records do not include complete records of the periodic calibration of laboratory instruments and apparatus.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Potable water standards not met 21 CFR 211.48(a)
  The potable water being permitted for use in the potable water system fails to meet standards prescribed by the Environmental Protection Agency.
• 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.
• Product identifier - record keeping FDCA 582(b)(2)(A)
  Your firm failed to maintain your product identifier information for at least 6 years.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.

May 25, 2022 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.

Sep 12, 2014 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 and reviewed and approved by the quality control unit.
• 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.
• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not derived from previous acceptable process average and process variability estimates where possible.

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