# FDA 483 - Blendpack, Inc. - November 01, 2024

Source: https://www.keypedia.com/records/483/blendpack-inc/b5afc9d5-0f2b-4d0e-bb4a-47016c344810

> FDA 483 for Blendpack, Inc. on November 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blendpack, Inc.
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Blendpack Inc, an OTC drug manufacturer in Cleveland, TN, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in quality control, including inadequate cGMP systems, failure to prevent microbial contamination in liquid aspirin products, lack of component identity testing, and an improperly designed and maintained deionized water system. These issues indicate a severe lack of quality oversight and control over drug manufacturing processes.

## Related Officers

- [Gretchen M. Laws](https://www.keypedia.com/people/gretchen-m-laws/9a3ecebd-099b-41d5-a2a7-70811a26cae1)
- [issuing_officer](https://www.keypedia.com/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.keypedia.com/companies/blendpack-inc/63506f6a-d561-478d-818c-68dabba41690

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea