# FDA 483 - Sunrider Manufacturing L P - July 03, 2019

Source: https://www.globalkeysolutions.net/records/483/sunrider-manufacturing-l-p/75b82be8-bc36-4703-a4d6-093a8b67fa08

> FDA 483 for Sunrider Manufacturing L P on July 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunrider Manufacturing L P
- Inspection Date: 2019-07-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Sunrider Manufacturing L P in Torrance, CA, an OTC drug manufacturer, received a Form 483 citing significant deficiencies during an FDA inspection from June to July 2019. The observations highlight failures in complaint handling, laboratory controls including data integrity and use of expired reagents, non-adherence to stability testing protocols, inadequate equipment cleaning documentation, and a lack of product-specific process validation. These issues collectively indicate a need for comprehensive improvements in the firm's quality management system.

## Related Officers

- [Stephanie A. Slater](https://www.globalkeysolutions.net/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

Company: https://www.globalkeysolutions.net/companies/sunrider-manufacturing-l-p/507de08b-9478-4d21-9a6b-93f286c71d0d

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