# FDA 483 - International Medication Systems Ltd. - December 19, 2025

Source: https://www.keypedia.com/records/483/international-medication-systems-ltd/f1068c45-4439-4ac7-a8e1-1333a7f04a38

> FDA 483 for International Medication Systems Ltd. on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Medication Systems Ltd.
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: International Medication Systems Ltd. in South El Monte, CA, a drug and API manufacturer, was cited with eight observations during an FDA inspection from December 9-19, 2025. The observations highlight significant deficiencies in aseptic processing environmental monitoring, equipment cleaning, laboratory controls, water system quality, and procedures for preventing microbiological contamination. Additionally, issues with DSCSA compliance and product identifier record retention were noted, indicating broad systemic failures in quality and regulatory adherence.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/international-medication-systems-ltd/bdb382cb-8147-4ebd-ae85-5c544d5daf01)
- [483 - 2022-05-25](https://www.keypedia.com/records/483/international-medication-systems-ltd/351c8cc0-c6e3-4383-9c71-c8c83542c31f)
- [483 - 2023-02-15](https://www.keypedia.com/records/483/international-medication-systems-ltd/c47575fe-f472-41eb-9e94-7cdec3b18d15)
- [WARNING_LETTER - 2025-12-19](https://www.keypedia.com/records/warning_letter/international-medication-systems-ltd/d75e7cab-5325-4569-9641-e6ee3b2afeb3)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)
- [Claudia M Perez-Komaraki](https://www.keypedia.com/people/claudia-m-perez-komaraki/2964b2cd-b322-4296-9b53-69c4b2fec4e5)
- [issuing_officer](https://www.keypedia.com/people/ngozi-g-offor/d9d0aa28-6bd1-4427-a712-8716c96b1f3d)

Company: https://www.keypedia.com/companies/international-medication-systems-ltd/d323d576-1c13-498f-af78-08d7cc187625

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6