# FDA 483 - Western Chemical Inc. - December 23, 2019

Source: https://www.globalkeysolutions.net/records/483/western-chemical-inc/88a669a2-e8f8-48ab-8762-b7fe25f36257

> FDA 483 for Western Chemical Inc. on December 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Western Chemical Inc.
- Inspection Date: 2019-12-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Syndel USA in Ferndale, WA, a drug manufacturer, was cited for significant deficiencies in its quality control unit and laboratory operations during an FDA inspection. Observations included failures to follow recall and corrective action procedures for a sub-potent product, inadequate laboratory controls with unqualified personnel verifying test results, and a lack of documented review for HPLC software audit trails to ensure data integrity. These issues indicate a systemic breakdown in ensuring product quality and data reliability.

## Related Documents

- [483 - 2022-04-14](https://www.globalkeysolutions.net/records/483/western-chemical-inc/e8ed27b6-e1c6-4fcd-9a52-e1780fe85977)
- [483 - 2024-10-23](https://www.globalkeysolutions.net/records/483/western-chemical-inc/280cc34d-d232-44d9-9a48-121e7abb424b)

## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.globalkeysolutions.net/companies/western-chemical-inc/f13bfcbc-06d5-4798-b88f-92e71ffad710

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