# FDA 483 - International Medication Systems Ltd. - February 15, 2023

Source: https://www.globalkeysolutions.net/records/483/international-medication-systems-ltd/c47575fe-f472-41eb-9e94-7cdec3b18d15

> FDA 483 for International Medication Systems Ltd. on February 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Medication Systems Ltd.
- Inspection Date: 2023-02-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of International Medication Systems Ltd. in South El Monte, CA, revealed significant deficiencies in data integrity and equipment maintenance. The firm failed to implement appropriate controls over computerized systems, allowing unauthorized data deletion and method editing, and lacked adequate audit trail procedures. Additionally, critical equipment parts were not included in a preventive maintenance schedule.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/international-medication-systems-ltd/bdb382cb-8147-4ebd-ae85-5c544d5daf01)
- [483 - 2022-05-25](https://www.globalkeysolutions.net/records/483/international-medication-systems-ltd/351c8cc0-c6e3-4383-9c71-c8c83542c31f)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Public Affairs Specialist](https://www.globalkeysolutions.net/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

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

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