# FDA EIR - Alliance Medical Products, Inc. DBA Siegfried Company - July 10, 2013

Source: https://www.keypedia.com/records/eir/alliance-medical-products-inc-dba-siegfried-company/7a1e9df1-04f8-4c6e-81a1-141a93d65b02

> FDA EIR for Alliance Medical Products, Inc. DBA Siegfried Company on July 10, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Alliance Medical Products, Inc. DBA Siegfried Company
- Inspection Date: 2013-07-10
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: **FDA Establishment Inspection Report Summary**

**Company:** Alliance Medical Products, Inc.  
**Location:** Irvine, CA  
**Inspection Dates:** July 10, 2013 - August 16, 2013  
**FEI Number:** 2027189  

**Main Violations/Issues:**
The inspection identified significant deficiencies in laboratory controls and procedures at Alliance Medical Products. The primary concerns included:

1. **Inadequate Validation:** Changes to testing methods, such as the HPLC determination of release rates, lacked proper validation. Specifically, the theoretical plate count requirements were altered without sufficient justification or re-validation, potentially compromising data accuracy.

2. **Sampling Plan Deficiencies:** The sampling plan for finished product testing was reduced without a valid rationale. The firm failed to provide data supporting that the reduced sample size was representative of the batch, raising concerns about the reliability of product quality assessments.

3. **In-Process Testing Concerns:** Changes from finished product release tests to in-process tests were made without demonstrating that these tests accurately represented the final product. Issues such as damage to drug inserts during ejection from the handpiece were not adequately addressed.

4. **Yield Alert and Action Limits:** The firm set yield alert and action limits at extremely low levels without proper justification, which could lead to inadequate investigation of production issues.

**Regulatory Framework:** The inspection was conducted under 21 CFR 211.160(b), which governs laboratory controls and ensures that drug products meet established standards of identity, strength, quality, and purity.

**Required Actions:**
Alliance Medical Products is required to address these deficiencies by:

- Providing a detailed response within 15 working days, outlining corrective actions for each observation.
- Validating changes to testing methods to ensure they meet regulatory standards.
- Justifying sampling plans and ensuring they are statistically valid.
- Reviewing and adjusting yield alert and action limits to reflect realistic production capabilities.

These actions are necessary to ensure compliance with FDA regulations and maintain product quality and safety

## Related Documents

- [EIR - 2013-08-16](https://www.keypedia.com/records/eir/alliance-medical-products-inc-dba-siegfried-company/e2dc6c16-4578-46a6-95d3-9a8bad157245)
- [483 - 2017-05-26](https://www.keypedia.com/records/483/alliance-medical-products-inc-dba-siegfried-company/83bbfc5d-f77f-4ccd-89ce-9c2db05e341a)
- [483 - 2021-05-21](https://www.keypedia.com/records/483/alliance-medical-products-inc-dba-siegfried-company/21c748df-9209-4f85-987a-939fc1e76072)
- [483 - 2025-11-07](https://www.keypedia.com/records/483/alliance-medical-products-inc-dba-siegfried-company/c9e0f9f1-3a0d-4415-af2b-48eba6d77484)

Company: https://www.keypedia.com/companies/alliance-medical-products-inc-dba-siegfried-company/3daf2f25-e22a-41c0-bcd9-d0f8ef1ab602

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b