# FDA 483 - International Medication Systems Ltd. - May 25, 2022

Source: https://www.globalkeysolutions.net/records/483/international-medication-systems-ltd/351c8cc0-c6e3-4383-9c71-c8c83542c31f

> FDA 483 for International Medication Systems Ltd. on May 25, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: International Medication Systems Ltd.
- Inspection Date: 2022-05-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: International Medication Systems Ltd. in South El Monte, CA, a manufacturer of sterile combination drugs and nonsterile API, was cited for a significant quality control issue. The inspection revealed that deviations from written production and process control procedures were not recorded and justified. This included an unrecorded set point increase during the manufacturing of stoppers, which were subsequently used in a distributed drug product.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/international-medication-systems-ltd/bdb382cb-8147-4ebd-ae85-5c544d5daf01)
- [483 - 2023-02-15](https://www.globalkeysolutions.net/records/483/international-medication-systems-ltd/c47575fe-f472-41eb-9e94-7cdec3b18d15)

## Related Officers

- [Senior CSO, Investigator](https://www.globalkeysolutions.net/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

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