# FDA 483 - AG Essence, Inc. - February 26, 2025

Source: https://www.keypedia.com/records/483/ag-essence-inc/ffb1d3c9-56de-497b-bd20-df38bdf0780d

> FDA 483 for AG Essence, Inc. on February 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AG Essence, Inc.
- Inspection Date: 2025-02-26
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: AG Essence, Inc. in Sandston, VA, a contract manufacturer of OTC animal drug products, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed failures in process validation, equipment cleaning procedures, raw material identity testing, and microbiological testing for product release. These issues collectively indicate a systemic breakdown in GMP compliance for their animal drug products, raising concerns about product quality and safety.

## Related Documents

- [WARNING_LETTER - 2024-01-22](https://www.keypedia.com/records/warning_letter/ag-essence-inc/992fa1dd-ffeb-4b59-831b-7eb0d2983f01)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.keypedia.com/companies/ag-essence-inc/4ece4267-a824-4a93-95a6-5d4432e8a770

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa