# FDA 483 - Mana Products, Inc. - September 25, 2025

Source: https://www.globalkeysolutions.net/records/483/mana-products-inc/9f9f72da-5c2c-4a86-8750-8e8ce608ab25

> FDA 483 for Mana Products, Inc. on September 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mana Products, Inc.
- Inspection Date: 2025-09-25
- Product Type: drugs
- Office Name: New York District Office
- Summary: Mana Products, Inc., an OTC drug manufacturer in Long Island City, NY, was cited for significant deficiencies in laboratory controls, quality control unit review of production records, and instrument calibration. The inspection revealed issues including unauthorized product specification changes, failure to investigate water system microbial contamination, and overdue calibration of critical monitoring equipment. These observations indicate a lack of adherence to established procedures and regulatory requirements for ensuring product quality and purity.

## Related Documents

- [483 - 2022-10-17](https://www.globalkeysolutions.net/records/483/mana-products-inc/9850af89-5d4f-4aec-ad09-efea0bd0807f)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)

Company: https://www.globalkeysolutions.net/companies/mana-products-inc/39136dd3-048e-42d7-9abd-088631ba6400

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