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

Analytics Overview

44
Form 483s Issued
13
483s converted to WL
46
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs
30 May 2025
Capricor, Inc.
Drugs
30 Jan 2025
Krystal Biotech, Inc.
Drugs
20 Dec 2024
SCA Pharmaceuticals, LLC
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
3
1
Bijoy Panicker
2
0
TITLE/ COMPANY Issue Date Status Details
Your firm failed to document and investigate Out of Specification results obtained by an unregistered facility
Hetero Labs Limited, Unit-IX
26 Sep 2025 Normal Justification: Supplier Quality Management is implicated due to the need for rigorous quality assurance practices with third-party service providers.
Excerpt: It was observed at the unregistered testing facility the OOS results were obtained, only passing results were documented at your firm.
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
GenoGenix, LLC
18 Jul 2025 Normal Justification: Supplier Quality Management is essential as the oversight of the supplier's analysis validity is lacking.
Excerpt: Established the reliability of supplier analyses through appropriate validation of supplier test results at defined intervals.
View Details
Quality agreements are not established between (b) (4) facilities and (b) (4)
Capricor, Inc.
30 May 2025 Normal Justification: Supplier Quality Management involves overseeing supplier compliance to CGMP, which requires clear agreements on roles and responsibilities.
Excerpt: no quality agreements have been established with multiple (b) (4) including the (b) (4) for (b) (4) at release, (b) (4) testing
View Details
Failure to check the reliability of Certificate of Analysis (COA) at Regular Intervals
Krystal Biotech, Inc.
30 Jan 2025 Normal Justification: Ensuring the reliability of supplier’s COA is a fundamental aspect of Supplier Quality Management to maintain material quality.
Excerpt: Your firm has not established the reliability of suppliers COA through appropriate validation of the supplier’s test result.
View Details
There is a failure to thoroughly review any unexplained discrepancy
SCA Pharmaceuticals, LLC
20 Dec 2024 Normal Justification: Supplier Quality Management is crucial as the observation highlights inadequacies in dealing with supplier-caused material defects.
Excerpt: Your firm continued to use them as container closures in your manufacturing activities.
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.

Written By
Vivek Gera
Reading Time
8
Minutes

Supplier Quality Management

Overview

44
Form 483s Issued
13
483s converted to WL
46
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs
30 May 2025
Capricor, Inc.
Drugs
30 Jan 2025
Krystal Biotech, Inc.
Drugs
20 Dec 2024
SCA Pharmaceuticals, LLC
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
3
1
Bijoy Panicker
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm failed to document and investigate Out of Specification results obtained by an unregistered facility
Hetero Labs Limited, Unit-IX
26 Sep 2025 Normal Justification: Supplier Quality Management is implicated due to the need for rigorous quality assurance practices with third-party service providers.
Excerpt: It was observed at the unregistered testing facility the OOS results were obtained, only passing results were documented at your firm.
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
GenoGenix, LLC
18 Jul 2025 Normal Justification: Supplier Quality Management is essential as the oversight of the supplier's analysis validity is lacking.
Excerpt: Established the reliability of supplier analyses through appropriate validation of supplier test results at defined intervals.
View Details
Quality agreements are not established between (b) (4) facilities and (b) (4)
Capricor, Inc.
30 May 2025 Normal Justification: Supplier Quality Management involves overseeing supplier compliance to CGMP, which requires clear agreements on roles and responsibilities.
Excerpt: no quality agreements have been established with multiple (b) (4) including the (b) (4) for (b) (4) at release, (b) (4) testing
View Details
Failure to check the reliability of Certificate of Analysis (COA) at Regular Intervals
Krystal Biotech, Inc.
30 Jan 2025 Normal Justification: Ensuring the reliability of supplier’s COA is a fundamental aspect of Supplier Quality Management to maintain material quality.
Excerpt: Your firm has not established the reliability of suppliers COA through appropriate validation of the supplier’s test result.
View Details
There is a failure to thoroughly review any unexplained discrepancy
SCA Pharmaceuticals, LLC
20 Dec 2024 Normal Justification: Supplier Quality Management is crucial as the observation highlights inadequacies in dealing with supplier-caused material defects.
Excerpt: Your firm continued to use them as container closures in your manufacturing activities.
View Details

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