# FDA 483 - Kohana Pharmacy and Center for Regenerative Medicine Inc. - April 10, 2019

Source: https://www.keypedia.com/records/483/kohana-pharmacy-and-center-for-regenerative-medicine-inc/53aa7ab8-817d-43e0-8196-65678cd3f013

> FDA 483 for Kohana Pharmacy and Center for Regenerative Medicine Inc. on April 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kohana Pharmacy and Center for Regenerative Medicine Inc.
- Inspection Date: 2019-04-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Kohana Pharmacy and Center for Regenerative Medicine Inc. in San Luis Obispo, CA, identified significant deficiencies in the production of non-sterile drug products. The firm was cited for using non-pharmaceutical grade components, specifically purified water, in drug formulations. Additionally, the inspection revealed inadequate cleaning procedures for work surfaces and utensils used in the production of hazardous drugs, posing a risk of cross-contamination.

## Related Documents

- [483 - 2019-04-17](https://www.keypedia.com/records/483/kohana-pharmacy-and-center-for-regenerative-medicine-inc/1eefe577-7d1b-464f-979b-913cce085d95)
- [STATE_REFERRAL_LETTER - 2019-04-10](https://www.keypedia.com/records/state_referral_letter/kohana-pharmacy-and-center-for-regenerative-medicine-inc/84ca508c-af92-4aba-9419-82d295f5dcce)

## Related Officers

- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/kohana-pharmacy-and-center-for-regenerative-medicine-inc/0cce486e-2e46-4cba-949b-3ad2c37cf4ce

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6