# FDA 483 - ContainMed, Inc. - February 19, 2020

Source: https://www.globalkeysolutions.net/records/483/containmed-inc/7cdf9e6c-578c-490f-b373-3a01ad418111

> FDA 483 for ContainMed, Inc. on February 19, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ContainMed, Inc.
- Inspection Date: 2020-02-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: ContainMed, Inc., a contract manufacturer in Indianapolis, IN, was inspected from February 12-19, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning the control of nonconforming product, rework procedures, and the maintenance of device history records. These issues indicate a lack of adequate documentation and established procedures for critical manufacturing and quality control processes.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

Company: https://www.globalkeysolutions.net/companies/containmed-inc/75c3e259-858b-4479-80c1-c58d1aee43c9

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0