# FDA 483 - AAA Pharmaceutical, Inc. - April 03, 2019

Source: https://www.keypedia.com/records/483/aaa-pharmaceutical-inc/0d44d71b-c849-4775-a502-5679f14945ec

> FDA 483 for AAA Pharmaceutical, Inc. on April 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AAA Pharmaceutical, Inc.
- Inspection Date: 2019-04-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of AAA Pharmaceutical, Inc. in Lumberton, NJ, a control testing laboratory and packager of OTC drugs, revealed significant deficiencies in their quality control unit's procedures and adherence to them. Observations included a lack of written procedures for critical operations like sampling and supplier monitoring, as well as a failure to properly review and approve changes to laboratory test methods. These issues indicate a systemic breakdown in maintaining adequate control over drug manufacturing processes.

## Related Documents

- [EIR - 2019-04-03](https://www.keypedia.com/records/eir/aaa-pharmaceutical-inc/95beacdd-197a-4ec8-b3a0-1c5f9e57d249)
- [483 - 2025-03-28](https://www.keypedia.com/records/483/aaa-pharmaceutical-inc/26bf10f7-11e8-4c0a-bc7f-87be30347209)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-l-casner/a0f35f37-4795-4edf-a9f6-a447d64c0fd4)

Company: https://www.keypedia.com/companies/aaa-pharmaceutical-inc/a4bd33c0-4805-416c-93f2-55e4116cc481

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