# FDA 483 - AACE Pharmaceuticals, Inc. - November 22, 2024

Source: https://www.keypedia.com/records/483/aace-pharmaceuticals-inc/c15321bc-630c-413c-aaf4-75dc26bdd909

> FDA 483 for AACE Pharmaceuticals, Inc. on November 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AACE Pharmaceuticals, Inc.
- Inspection Date: 2024-11-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: AACE Pharmaceuticals, Inc. in Fairfield, NJ, a drug manufacturer, received a Form 483 citing significant deficiencies in its operations. The observations highlight a lack of adequate quality control unit oversight, particularly concerning contract manufacturing organizations and data integrity, alongside poor equipment and facility maintenance. Additionally, the firm failed to adhere to its own established procedures for laboratory reagent control and document management.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/aace-pharmaceuticals-inc/adaafe81-4985-445f-ab9f-cae7218a0c52)
- [483 - 2020-08-10](https://www.keypedia.com/records/483/aace-pharmaceuticals-inc/96728241-ee60-4926-afdd-30a846dd0093)
- [WARNING_LETTER - 2024-11-22](https://www.keypedia.com/records/warning_letter/aace-pharmaceuticals-inc/32ee006f-8e69-441e-99f6-2acc5dac22dc)

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)
- [Armen H. Youssoufian](https://www.keypedia.com/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)

Company: https://www.keypedia.com/companies/aace-pharmaceuticals-inc/96df8dd4-4462-4c9d-9874-1e1f004aad14

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248