# FDA 483 - PharmPak, Inc. - December 09, 2021

Source: https://www.globalkeysolutions.net/records/483/pharmpak-inc/b8a38293-d707-4e86-a001-b43b6508a3e6

> FDA 483 for PharmPak, Inc. on December 09, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharmPak, Inc.
- Inspection Date: 2021-12-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: PharmPak, Inc. in San Rafael, CA, a repackager/relabeler, was inspected by the FDA from December 1-9, 2021. The inspection revealed significant and repeat deficiencies across multiple areas, including inadequate validation of test methods and equipment, lack of proper air handling systems, and failure to establish and follow written procedures for cleaning, maintenance, quality control, and annual product reviews. These issues indicate a systemic lack of adherence to good manufacturing practices for drug products.

## Related Officers

- [Stryker, Regulatory Affairs](https://www.globalkeysolutions.net/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)
- [Matthew R. Clabeaux](https://www.globalkeysolutions.net/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)

Company: https://www.globalkeysolutions.net/companies/pharmpak-inc/fccd496e-9ef9-4d5c-a4ae-759128348f4d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b