# FDA 483 - Future Pak LLC - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/future-pak-llc/a309f597-589b-4f5f-ae4e-5e000c076762

> FDA 483 for Future Pak LLC on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Future Pak LLC
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected Future Pak, Ltd, a drug product packager in Wixom, MI, from December 9-12, 2019. The inspection revealed significant deficiencies in quality control unit procedures, facility design for preventing mix-ups and contamination, equipment qualification and verification, and cleaning and maintenance procedures for manufacturing equipment. These observations indicate a lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2024-10-15](https://www.globalkeysolutions.net/records/483/future-pak-llc/7c20256d-a6d3-42f5-95ad-822b817c4598)

## Related Officers

- [Daniel L Obrist](https://www.globalkeysolutions.net/people/daniel-l-obrist/09792fbb-8d5c-42f2-87f6-a9cb59f17f78)
- [Investigator](https://www.globalkeysolutions.net/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

Company: https://www.globalkeysolutions.net/companies/future-pak-llc/a165267b-2c62-4234-9b40-3ef65126ad18

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0