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Sub System /
Distribution
Distribution
View Detailed Analysis

Analytics Overview

8
Form 483s Issued
2
483s converted to WL
9
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
12 Jul 2024
Lonza Netherlands B.V.
Drugs
View Form 483
06 Mar 2024
GSK Vaccines GmbH
Drugs
View Form 483
08 Sep 2023
Sichuan Deebio Pharmaceutical Co. Ltd.
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
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
Documents and (b) (4) used for distribution of the (b) (4) drug products are deficient
GSK Vaccines GmbH		 06 Mar 2024 Normal Justification: Shipment documents do not reflect accurate stability data, a distribution oversight.
Excerpt: Documentations that accompanied the shipment, including the packing lists, contain incorrect information.
View Details
Control procedures are not established which validate the performance of distribution processes
Sichuan Deebio Pharmaceutical Co. Ltd.		 08 Sep 2023 Normal Justification: Distribution is fundamentally linked to this observation as it involves the processes ensuring that the drug substance remains within specified conditions during shipping.
Excerpt: your firm ships USP drug substance with temperature storage specifications of (1) (b) (b) to (4) degrees Celsius for temperature, and (b) (4) % RH. There is no official validation study regarding the shipping container and components used which provide assurance that the (b) (4) USP drug substance in transit stays within its specified range for the duration of the shipment.
View Details

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Go back

Distribution

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
Share

Distribution

Overview

8
Form 483s Issued
2
483s converted to WL
9
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
12 Jul 2024
Lonza Netherlands B.V.
Drugs
View Form 483
06 Mar 2024
GSK Vaccines GmbH
Drugs
View Form 483
08 Sep 2023
Sichuan Deebio Pharmaceutical Co. Ltd.
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
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
Documents and (b) (4) used for distribution of the (b) (4) drug products are deficient
GSK Vaccines GmbH		 06 Mar 2024 Normal Justification: Shipment documents do not reflect accurate stability data, a distribution oversight.
Excerpt: Documentations that accompanied the shipment, including the packing lists, contain incorrect information.
View Details
Control procedures are not established which validate the performance of distribution processes
Sichuan Deebio Pharmaceutical Co. Ltd.		 08 Sep 2023 Normal Justification: Distribution is fundamentally linked to this observation as it involves the processes ensuring that the drug substance remains within specified conditions during shipping.
Excerpt: your firm ships USP drug substance with temperature storage specifications of (1) (b) (b) to (4) degrees Celsius for temperature, and (b) (4) % RH. There is no official validation study regarding the shipping container and components used which provide assurance that the (b) (4) USP drug substance in transit stays within its specified range for the duration of the shipment.
View Details

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