# FDA 483 - Positive Promotions - April 25, 2022

Source: https://www.globalkeysolutions.net/records/483/positive-promotions/7ecf2476-5b49-4c45-932f-cf669a4ae5b4

> FDA 483 for Positive Promotions on April 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Positive Promotions
- Inspection Date: 2022-04-25
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Positive Promotions, a repacker/relabeler of OTC drug products including hand sanitizers, sunscreens, and lip balms, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, proper procedures for handling product complaints, and an adequate system for product traceability and recall. These issues indicate a severe lack of adherence to Good Manufacturing Practices for drug products.

## Related Documents

- [483 - 2025-02-07](https://www.globalkeysolutions.net/records/483/positive-promotions/ce3ebc9e-b310-4882-bb4d-1c1d975ec16f)

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Investigator](https://www.globalkeysolutions.net/people/craig-d-zagata/1e9614e4-4efe-4d11-8b85-9fd43b64d40c)

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

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