# FDA 483 - AHC Products Inc - October 23, 2025

Source: https://www.keypedia.com/records/483/ahc-products-inc/2a179d89-9bc8-4a03-a9c1-362a8bb3b48b

> FDA 483 for AHC Products Inc on October 23, 2025. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AHC Products Inc
- Inspection Date: 2025-10-23
- Product Type: veterinary
- Summary: An FDA inspection of "viagra" from October 20-23, 2025, revealed nine significant observations indicating non-compliance with Good Manufacturing Practices for drug products. The company failed to establish adequate written procedures for production and process controls, specifically lacking validation for the manufacturing process of its topical anti-infective, PM DO. Finished product testing was insufficient, with lots released based solely on visual assessment instead of laboratory conformance. Identity testing for incoming raw materials, including active ingredients like DO, was not performed. Critical manufacturing equipment, such as DOO HPA and M2 HEE, lacked qualification for intended use, and change control procedures were not followed.

Furthermore, the firm had no written program for assessing drug product stability, resulting in products like GREEN lacking stability testing and expiration dates on labels. Inadequate deviation investigations were noted, often lacking scientific justification and comprehensive corrective actions, and stability samples were not consistently tested at required intervals, a repeated issue. Laboratory records were incomplete, with Certificates of Analysis reporting results for microbiological hazards and heavy metals without actual testing. Batch records contained inaccurate yield calculations, and critical equipment maintenance was not performed at appropriate intervals, which was also a repeated observation. The firm is required to address these regulatory observations by implementing comprehensive corrective and preventative actions.

## Related Documents

- [483 - 2022-03-29](https://www.keypedia.com/records/483/ahc-products-inc/ceb49afb-7e87-4ba4-98f9-c264d4adab2e)
- [483 - 2025-10-23](https://www.keypedia.com/records/483/ahc-products-inc/82417e0f-b613-4b90-96d4-f14315c9cae4)

## Related Officers

- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.keypedia.com/companies/ahc-products-inc/4d6352d5-7905-4be6-9151-3c7345e363fe