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Sub System /
Supplier Quality Management
Supplier Quality Management
View Detailed Analysis

Analytics Overview

72
Form 483s Issued
13
483s converted to WL
76
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
07 Aug 2026
Neeyaan LLC
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs
20 Mar 2026
Eosera, Inc.
Drugs
10 Mar 2026
COSMETIC LABORATORY INC
Drugs
06 Mar 2026
IsoTis OrthoBiologics, Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Anastasia M Shields
4
4
Justin A Boyd
4
4
Crystal Monroy
4
1
Carl Perez
3
0
TITLE/ COMPANY Issue Date Status Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications
Neeyaan LLC
07 Aug 2026 Normal Justification: Supplier Quality Management is central as reliance was placed on supplier's COAs without due verification.
Excerpt: You relied on your suppliers' certificate of analysis (COA) without establishing the reliability of each analysis.
View Details
OBJECTIVE 1b: A sound and appropriate program for sampling, testing, and evaluating components
Not available
29 Jun 2026 Normal Justification: Effective supplier quality management is needed to address component variability and ensure specification compliance.
Excerpt: Evaluate the suppliers' variability and the specification criteria.
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: Supplier Quality Management is implicated due to the nonexistence of supplier qualification protocols.
Excerpt: There are no written procedures for qualifying suppliers of raw materials and APIs.
View Details
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality
Eosera, Inc.
20 Mar 2026 Normal Justification: Reliance on supplier CoA without adequate USP verification indicates supplier management process deficiencies.
Excerpt: The supplier's CoA does not include USP methods/compendial claims.
View Details
Control procedures fail to include adequate steps to ensure that manufacturers know the identity of each batch of material
Grifols Diagnostic Solutions
13 Mar 2026 Normal Justification: The failure to verify suppliers indicates a lapse in Supplier Quality Management processes.
Excerpt: B) There was no system in place to verify that all suppliers of critical raw materials were qualified before materials were approved for use in production.
View Details

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Supplier Quality Management

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Supplier Quality Management

Overview

72
Form 483s Issued
13
483s converted to WL
76
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
07 Aug 2026
Neeyaan LLC
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs
20 Mar 2026
Eosera, Inc.
Drugs
10 Mar 2026
COSMETIC LABORATORY INC
Drugs
06 Mar 2026
IsoTis OrthoBiologics, Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Anastasia M Shields
4
4
Justin A Boyd
4
4
Crystal Monroy
4
1
Carl Perez
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications
Neeyaan LLC
07 Aug 2026 Normal Justification: Supplier Quality Management is central as reliance was placed on supplier's COAs without due verification.
Excerpt: You relied on your suppliers' certificate of analysis (COA) without establishing the reliability of each analysis.
View Details
OBJECTIVE 1b: A sound and appropriate program for sampling, testing, and evaluating components
Not available
29 Jun 2026 Normal Justification: Effective supplier quality management is needed to address component variability and ensure specification compliance.
Excerpt: Evaluate the suppliers' variability and the specification criteria.
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: Supplier Quality Management is implicated due to the nonexistence of supplier qualification protocols.
Excerpt: There are no written procedures for qualifying suppliers of raw materials and APIs.
View Details
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality
Eosera, Inc.
20 Mar 2026 Normal Justification: Reliance on supplier CoA without adequate USP verification indicates supplier management process deficiencies.
Excerpt: The supplier's CoA does not include USP methods/compendial claims.
View Details
Control procedures fail to include adequate steps to ensure that manufacturers know the identity of each batch of material
Grifols Diagnostic Solutions
13 Mar 2026 Normal Justification: The failure to verify suppliers indicates a lapse in Supplier Quality Management processes.
Excerpt: B) There was no system in place to verify that all suppliers of critical raw materials were qualified before materials were approved for use in production.
View Details

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