# FDA 483 - Positive Promotions - February 07, 2025

Source: https://www.keypedia.com/records/483/positive-promotions/ce3ebc9e-b310-4882-bb4d-1c1d975ec16f

> FDA 483 for Positive Promotions on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Positive Promotions
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: New York District Office
- Summary: Positive Promotions, an OTC drug repackager and relabeler in Hauppauge, NY, received a Form FDA 483 with five observations. The firm was cited for failing to establish written procedures for production and process controls, including equipment qualification and supplier reliability validation. Additionally, deficiencies were noted in quality control unit procedures, batch record documentation, and employee GMP training, indicating a lack of adherence to current Good Manufacturing Practices.

## Related Documents

- [483 - 2022-04-25](https://www.keypedia.com/records/483/positive-promotions/7ecf2476-5b49-4c45-932f-cf669a4ae5b4)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.keypedia.com/companies/positive-promotions/785c06fc-4675-4569-98b1-b1e93bd7d4d4

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d