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Sub System /
Distribution
Distribution
View Detailed Analysis

Analytics Overview

11
Form 483s Issued
2
483s converted to WL
12
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
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
06 Mar 2025
Sterling Distributors, LLC
Drugs
View Form 483
24 Feb 2025
A2A Integrated Logistic Inc
Drugs
View Form 483
12 Jul 2024
Lonza Netherlands B.V.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
2
2
Michael L Jones
2
2
Jocelyn C Turner
2
2
Lauren R Brady
2
2
Preston B Hoover
2
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your firm released finished API's and intermediates intended for the US market to an offsite API warehouse without documentation.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The distribution to an offsite warehouse without documentation relates to 'Distribution,' crucial for maintaining chain of custody.
Excerpt: Since these active pharmaceutical ingredients and materials were released to a warehouse outside of your firm’s control without documentation of shipping or receipt of the shipments.
View Details
Batch production and control records are not prepared for each batch of drug product produced
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The lack of distribution records with essential data affects the Distribution process compliance.
Excerpt: you were unable to provide distribution records containing the required elements including name, strength, dosage form, recipient name and address.
View Details
From August 2024 to February 2025, your firm engaged in wholesale distribution
Sterling Distributors, LLC		 06 Mar 2025 Normal Justification: Distribution is linked to this observation due to the unlicensed wholesale activity and shipment of counterfeit drugs as outlined in the observation.
Excerpt: Your firm engaged in wholesale distribution of prescription drug products without being appropriately licensed as required by section 503(e) of the FD&C Act.
View Details
Your firm failed to work with only Authorized Trading Partners as required by section 582(c)(3) of the FD&C Act
A2A Integrated Logistic Inc		 24 Feb 2025 Normal Justification: Distribution processes must ensure that all recipients are authorized, aligning with legislative compliance.
Excerpt: Your firm purchased product from Trading Partner E and distributed it to Trading Partner C by means of a drop shipment.
View Details
The process (equipment and procedures) for the storage and shipment of commercial drug product (DP) has not been validated
Lonza Netherlands B.V.		 12 Jul 2024 Normal Justification: Distribution processes are affected as they require validated methods for shipping drug products.
Excerpt: The proposed commercial DP shipping validation study has not been performed.
View Details

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Distribution

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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Distribution

Overview

11
Form 483s Issued
2
483s converted to WL
12
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
06 Mar 2025
Sterling Distributors, LLC
Drugs
View Form 483
24 Feb 2025
A2A Integrated Logistic Inc
Drugs
View Form 483
12 Jul 2024
Lonza Netherlands B.V.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
2
2
Michael L Jones
2
2
Jocelyn C Turner
2
2
Lauren R Brady
2
2
Preston B Hoover
2
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm released finished API's and intermediates intended for the US market to an offsite API warehouse without documentation.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The distribution to an offsite warehouse without documentation relates to 'Distribution,' crucial for maintaining chain of custody.
Excerpt: Since these active pharmaceutical ingredients and materials were released to a warehouse outside of your firm’s control without documentation of shipping or receipt of the shipments.
View Details
Batch production and control records are not prepared for each batch of drug product produced
GenoGenix, LLC		 18 Jul 2025 Normal Justification: The lack of distribution records with essential data affects the Distribution process compliance.
Excerpt: you were unable to provide distribution records containing the required elements including name, strength, dosage form, recipient name and address.
View Details
From August 2024 to February 2025, your firm engaged in wholesale distribution
Sterling Distributors, LLC		 06 Mar 2025 Normal Justification: Distribution is linked to this observation due to the unlicensed wholesale activity and shipment of counterfeit drugs as outlined in the observation.
Excerpt: Your firm engaged in wholesale distribution of prescription drug products without being appropriately licensed as required by section 503(e) of the FD&C Act.
View Details
Your firm failed to work with only Authorized Trading Partners as required by section 582(c)(3) of the FD&C Act
A2A Integrated Logistic Inc		 24 Feb 2025 Normal Justification: Distribution processes must ensure that all recipients are authorized, aligning with legislative compliance.
Excerpt: Your firm purchased product from Trading Partner E and distributed it to Trading Partner C by means of a drop shipment.
View Details
The process (equipment and procedures) for the storage and shipment of commercial drug product (DP) has not been validated
Lonza Netherlands B.V.		 12 Jul 2024 Normal Justification: Distribution processes are affected as they require validated methods for shipping drug products.
Excerpt: The proposed commercial DP shipping validation study has not been performed.
View Details

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