# FDA 483 - Packaging On Demand, Inc. - January 13, 2023

Source: https://www.keypedia.com/records/483/packaging-on-demand-inc/dade4453-64d1-4606-b332-50e7914db6e0

> FDA 483 for Packaging On Demand, Inc. on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Packaging On Demand, Inc.
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Packaging On Demand, Inc. in San Clemente, CA, a drug manufacturer, was inspected by the FDA and received nine observations. The inspection revealed significant deficiencies in quality control, batch record review, component testing, stability programs, and computer system controls. Several observations were repeats from a previous inspection, indicating persistent issues with GMP compliance.

## Related Documents

- [483 - 2021-10-18](https://www.keypedia.com/records/483/packaging-on-demand-inc/efcaba9b-e90d-4f0a-a9c1-e50b3c86e114)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

Company: https://www.keypedia.com/companies/packaging-on-demand-inc/5bdb7fe3-4144-411f-9267-3fbc3f555c24

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