# FDA 483 - Kirkman Laboratories, Inc. - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/kirkman-laboratories-inc/a2d06fbc-84f1-4893-b7ac-bb4f84f23651

> FDA 483 for Kirkman Laboratories, Inc. on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kirkman Laboratories, Inc.
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Kirkman Laboratories, Inc. in Lake Oswego, OR, was cited for significant deficiencies in its quality control unit, laboratory controls, and stability program during an FDA inspection. Observations included a lack of written quality agreements, unapproved procedures, missing annual product reviews, and inadequate stability testing and data integrity practices. Several issues, such as the quality control unit and investigation failures, were repeat observations.

## Related Officers

- [Compliance Officer / Investigator](https://www.globalkeysolutions.net/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.globalkeysolutions.net/companies/kirkman-laboratories-inc/2a480953-85fb-427c-a213-e4123ed15a66

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822