# FDA 483 - Copperhead Chemical Company, Inc. - June 18, 2026

Source: https://www.keypedia.com/records/483/copperhead-chemical-company-inc/2971b050-4bb0-4e96-a1c1-e95d4a5837ec

> FDA 483 for Copperhead Chemical Company, Inc. on June 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Copperhead Chemical Company, Inc.
- Inspection Date: 2026-06-18
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Copperhead Chemical Company, Inc. in Tamaqua, PA, revealed significant deficiencies in manufacturing controls. Observations included inadequate cleaning validation for API drug substance equipment, insufficient out-of-specification investigation processes, and improper monitoring of warehouse storage temperatures. These issues indicate a lack of robust quality systems.

## Related Documents

- [EIR - 2023-04-24](https://www.keypedia.com/records/eir/copperhead-chemical-company-inc/bb372e10-7018-49bf-ae71-22c63cb9e9a5)
- [483 - 2023-04-24](https://www.keypedia.com/records/483/copperhead-chemical-company-inc/41c87bca-c494-4360-ae3c-b6869cfe6745)

## Related Officers

- [John D. McIntosh](https://www.keypedia.com/people/john-d-mcintosh/063cac5b-0933-4ecf-a9fb-835dd5d25ef2)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/copperhead-chemical-company-inc/2a432c57-623a-4410-b45b-6f0d44eb7f40

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8