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

Analytics Overview

54
Form 483s Issued
13
483s converted to WL
58
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
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
31 Oct 2025
Lonza Guangzhou Pharmaceutical Ltd.
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483

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
Jonya M. Sonya M. Edmonds, Investigator
3
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Reports of analysis from component suppliers are accepted in lieu of testing
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Supplier Quality Management is pertinent due to the need for credible and verified material supply chains.
Excerpt: without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results.
View Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: Issues with unverified supplier documentation directly link to Supplier Quality Management failings.
Excerpt: Your firm also failed to validate and establish the reliability of your component supplier's test analyses.
View Details
The quality system that approves contract laboratories to perform testing of (b)(4) impurities is deficient.
Lonza Guangzhou Pharmaceutical Ltd.		 31 Oct 2025 Normal Justification: Supplier Quality Management involves the qualification and oversight of contract labs, ensuring they meet testing requirements.
Excerpt: The quality unit fails to ensure that the contract laboratory used to perform testing 01(b) (4) content...has the capabilities, equipment, and the knowledge...
View 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

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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.

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Supplier Quality Management

Overview

54
Form 483s Issued
13
483s converted to WL
58
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

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

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
31 Oct 2025
Lonza Guangzhou Pharmaceutical Ltd.
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483

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
Jonya M. Sonya M. Edmonds, Investigator
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Reports of analysis from component suppliers are accepted in lieu of testing
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Supplier Quality Management is pertinent due to the need for credible and verified material supply chains.
Excerpt: without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results.
View Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: Issues with unverified supplier documentation directly link to Supplier Quality Management failings.
Excerpt: Your firm also failed to validate and establish the reliability of your component supplier's test analyses.
View Details
The quality system that approves contract laboratories to perform testing of (b)(4) impurities is deficient.
Lonza Guangzhou Pharmaceutical Ltd.		 31 Oct 2025 Normal Justification: Supplier Quality Management involves the qualification and oversight of contract labs, ensuring they meet testing requirements.
Excerpt: The quality unit fails to ensure that the contract laboratory used to perform testing 01(b) (4) content...has the capabilities, equipment, and the knowledge...
View 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

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