# FDA 483 - Hawaii Pharm LLC - November 07, 2019

Source: https://www.keypedia.com/records/483/hawaii-pharm-llc/5580d04e-f9a0-4a6f-bd1f-71cce92b8436

> FDA 483 for Hawaii Pharm LLC on November 07, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hawaii Pharm LLC
- Inspection Date: 2019-11-07
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Hawaii Pharm LLC in Honolulu, HI, a dietary supplement manufacturer, revealed significant deficiencies in their manufacturing processes. The firm failed to establish identity and product specifications, prepare master manufacturing and batch production records, and maintain proper complaint handling procedures. Additionally, issues were noted with reserve sample collection and supplier qualification documentation, indicating a broad lack of adherence to good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2019-11-07](https://www.keypedia.com/records/warning_letter/hawaii-pharm-llc/0822f50b-50c2-4679-9732-3407c4848a8a)

## Related Officers

- [Kenneth Boehnen](https://www.keypedia.com/people/kenneth-boehnen/70d64816-c738-4864-87d3-9511cf314481)

Company: https://www.keypedia.com/companies/hawaii-pharm-llc/c9d896a9-53a9-4a58-a9ee-64738d91471c

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