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

Source: https://www.keypedia.com/records/483/robinson-pharma-inc/ba5a688e-41ae-404c-8f14-9ba95a048bcf

> 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: Los Angeles District Office
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) from August 24 to August 30, 2017, Robinson Pharma Inc., a dietary supplement manufacturer located in Santa Ana, CA, received a Form FDA 483 detailing an observation regarding its quality control processes. The primary issue identified was that the company's quality control operations failed to consistently review and approve all batch production records prior to product shipment. Specifically, two instances were cited where complete batch records and final Certificates of Analysis (CoA) were not finalized and signed for release until after the respective product lots had already been shipped to customers. For example, a product manufactured on May 5, 2017, was shipped on June 27, 2017, but its batch records were not reviewed and signed for release until August 4, 2017. This observation indicates a deviation from established regulatory expectations for dietary supplement manufacturing, which emphasize the importance of robust quality control and record-keeping practices to ensure product quality and safety before distribution. Robinson Pharma Inc. is responsible for conducting internal self-audits and implementing corrective actions to address this finding and ensure compliance with quality system requirements.

## 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/520055a7-d707-43e2-aa24-11ee64f8a2d8)

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)
- [Director of Compliance](https://www.keypedia.com/people/daniel-do-khanh/ed2cde8b-ab8e-467d-a5de-ebfb2dcd4834)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b