# FDA 483 - AACE Pharmaceuticals, Inc. - August 10, 2020

Source: https://www.globalkeysolutions.net/records/483/aace-pharmaceuticals-inc/96728241-ee60-4926-afdd-30a846dd0093

> FDA 483 for AACE Pharmaceuticals, Inc. on August 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AACE Pharmaceuticals, Inc.
- Inspection Date: 2020-08-10
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of AACE Pharmaceuticals, Inc. in Fairfield, NJ, revealed significant deficiencies in equipment maintenance and laboratory controls. Inspectors observed reactive equipment surfaces due to sticky tape on tablet presses, which could compromise drug product quality. Additionally, the firm failed to retain original electronic laboratory data, instead relying on cell phone photographs, and did not properly document or review "Single Injection Run" test injections.

## Related Documents

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- [483 - 2024-11-22](https://www.globalkeysolutions.net/records/483/aace-pharmaceuticals-inc/c15321bc-630c-413c-aaf4-75dc26bdd909)
- [WARNING_LETTER - 2024-11-22](https://www.globalkeysolutions.net/records/warning_letter/aace-pharmaceuticals-inc/32ee006f-8e69-441e-99f6-2acc5dac22dc)

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

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

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