# FDA 483 - Western Chemical Inc. - April 14, 2022

Source: https://www.keypedia.com/records/483/western-chemical-inc/e8ed27b6-e1c6-4fcd-9a52-e1780fe85977

> FDA 483 for Western Chemical Inc. on April 14, 2022. Product: veterinary. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Western Chemical Inc.
- Inspection Date: 2022-04-14
- Product Type: veterinary
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Syndel USA, a veterinary drug manufacturer in Ferndale, WA, was cited for significant deficiencies across four observations. The inspection revealed inadequate investigations into product stability failures, incomplete batch production records lacking critical raw material identification and investigation documentation, and failures in maintaining sanitary conditions and proper material handling in the warehouse. Additionally, the firm did not perform complete elemental impurity testing for its drug products.

## Related Documents

- [483 - 2019-12-23](https://www.keypedia.com/records/483/western-chemical-inc/88a669a2-e8f8-48ab-8762-b7fe25f36257)
- [483 - 2024-10-23](https://www.keypedia.com/records/483/western-chemical-inc/280cc34d-d232-44d9-9a48-121e7abb424b)

## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

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

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