# FDA 483 - Packaging On Demand, Inc. - October 18, 2021

Source: https://www.keypedia.com/records/483/packaging-on-demand-inc/efcaba9b-e90d-4f0a-a9c1-e50b3c86e114

> FDA 483 for Packaging On Demand, Inc. on October 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Packaging On Demand, Inc.
- Inspection Date: 2021-10-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Packaging On Demand Inc. in San Clemente, CA, a drug manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to ensure proper quality control unit review and approval before drug product release, did not adequately investigate out-of-specification results, and lacked annual product reviews. Additionally, issues were noted with component testing, laboratory record completeness, and electronic data integrity, including the absence of controls to prevent raw data deletion and a lack of data backup.

## Related Documents

- [483 - 2023-01-13](https://www.keypedia.com/records/483/packaging-on-demand-inc/dade4453-64d1-4606-b332-50e7914db6e0)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

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