# FDA 483 - Copperhead Chemical Company, Inc. - April 24, 2023

Source: https://www.keypedia.com/records/483/copperhead-chemical-company-inc/41c87bca-c494-4360-ae3c-b6869cfe6745

> FDA 483 for Copperhead Chemical Company, Inc. on April 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Copperhead Chemical Company, Inc.
- Inspection Date: 2023-04-24
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Copperhead Chemical Company, Inc. in Tamaqua, PA, was inspected by the FDA from April 17-24, 2023, and received a Form 483 with three observations. The inspection revealed significant issues related to inadequate discrepancy investigations, insufficient calibration of critical equipment used in nitroglycerin production, and a lack of data integrity controls for analytical testing systems. These findings indicate serious deficiencies in the firm's quality control and data management practices.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

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