# FDA 483 - Robinson Pharma Inc - August 30, 2017

Source: https://www.keypedia.com/records/483/robinson-pharma-inc/520055a7-d707-43e2-aa24-11ee64f8a2d8

> FDA 483 for Robinson Pharma Inc on August 30, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robinson Pharma Inc
- Inspection Date: 2017-08-30
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Robinson Pharma Inc, a dietary supplement manufacturer in Santa Ana, CA, was inspected by the FDA from August 24-30, 2017. The inspection revealed that the firm's quality control operations failed to review and approve all batch production-related records. Specifically, products were shipped to customers before final Certificates of Analysis were generated and before all batch records were reviewed and signed for release.

## Related Documents

- [483 - 2014-09-25](https://www.keypedia.com/records/483/robinson-pharma-inc/868db067-3902-4c92-9933-55749319fee1)
- [483 - 2014-09-25](https://www.keypedia.com/records/483/robinson-pharma-inc/b05f3735-a912-4f9a-b960-acccb1ea728e)
- [483 - 2017-08-30](https://www.keypedia.com/records/483/robinson-pharma-inc/ba5a688e-41ae-404c-8f14-9ba95a048bcf)

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/robinson-pharma-inc/2c89f954-9e61-4c8f-919a-595be7142b68

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