# FDA 483 - Tarry Medical Products, Inc. - October 09, 2025

Source: https://www.globalkeysolutions.net/records/483/tarry-medical-products-inc/219ca6a0-c2fc-4b7f-8e0d-538887478243

> FDA 483 for Tarry Medical Products, Inc. on October 09, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tarry Medical Products, Inc.
- Inspection Date: 2025-10-09
- Product Type: Drugs
- Office Name: New England District Office
- Summary: **FDA 483 Summary for Tarry Medical Products, Inc.**

**Company Name:** Tarry Medical Products, Inc.  
**Inspection Dates:** September 29, 2025 - October 9, 2025  
**Location:** Danbury, CT  
**FEI Number:** 3003382386  
**Individual Addressed:** Scott Bell, President  

**Main Violations/Issues:**
1. **Quality Control Deficiencies:** The quality control unit lacks the authority to approve or reject drug products. The firm released multiple batches that failed assay specifications by loosening these specifications without proper health hazard assessments.
   
2. **Specification Widening:** The firm failed to evaluate the impact of specification widening for certain products, allowing batches with out-of-specification (OOS) results to be released without appropriate change controls.

3. **Unvalidated Protocols:** The company instructed customers to use unvalidated protocols to address product issues, potentially affecting the product's identity, strength, purity, quality, or stability.

4. **Stability Testing Lapses:** Stability testing results are not used to determine storage conditions or expiration dates. The firm authorized the cessation of stability studies for a drug product, resulting in a lack of ongoing stability data for 2023-2025.

**Regulatory Framework:** The observations are based on FDA regulations that require pharmaceutical companies to maintain robust quality control systems and ensure product specifications are met without unauthorized adjustments.

**Required Actions:**
- Empower the quality control unit with the necessary authority to approve or reject drug products.
- Conduct comprehensive health hazard assessments for specification changes.
- Validate all protocols used to address product issues and ensure they do not compromise product quality.
- Resume stability studies to ensure accurate determination of storage conditions and expiration dates.

These observations require prompt corrective actions to ensure compliance with FDA regulations and maintain product integrity.

## Related Documents

- [483 - 2025-10-09](https://www.globalkeysolutions.net/records/483/tarry-medical-products-inc/f7789852-3d64-4419-b99b-a28ffe62e8d1)

## Related Officers

- [Josh Renzo N. Ramilo](https://www.globalkeysolutions.net/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Martin M. Kimani](https://www.globalkeysolutions.net/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

Company: https://www.globalkeysolutions.net/companies/tarry-medical-products-inc/4232a4f4-5bb2-4522-87ab-15d091f35695

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144