# FDA 483 - Packaging On Demand, Inc. - September 27, 2024

Source: https://www.keypedia.com/records/483/packaging-on-demand-inc/c194062b-f92d-401e-9ee6-58b8f889411e

> FDA 483 for Packaging On Demand, Inc. on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Packaging On Demand, Inc.
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: The FDA inspected Packaging On Demand, Inc. in San Clemente, CA, a contract OTC drug manufacturer, revealing significant deficiencies across multiple systems. The firm failed to perform adequate identification testing of active ingredients, maintain proper reserve samples, and ensure appropriate equipment qualification and cleaning validation. Additionally, issues were noted with process validation, component sampling, and inventory control, indicating a lack of robust quality oversight for their OTC drug products.

## Related Documents

- [483 - 2021-10-18](https://www.keypedia.com/records/483/packaging-on-demand-inc/efcaba9b-e90d-4f0a-a9c1-e50b3c86e114)
- [483 - 2023-01-13](https://www.keypedia.com/records/483/packaging-on-demand-inc/dade4453-64d1-4606-b332-50e7914db6e0)

## Related Officers

- [Pearl C. Ozuruigbo](https://www.keypedia.com/people/pearl-c-ozuruigbo/28ec383e-a602-4764-8d14-20b1049f93d7)
- [Wenzheng Zhang](https://www.keypedia.com/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b