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Sub System /
Material Receipt and Handling
Material Receipt and Handling
View Detailed Analysis

Analytics Overview

48
Form 483s Issued
9
483s converted to WL
53
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
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Demario L Walls
3
2
José E Melendez
3
0
Arsen Karapetyan
3
0
Christopher R Czajka
3
0
Alan M Barker
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The raw materials and quantities documented in the batch production records do not support the actual yields observed for the APIs produced at your firm.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: Effective material handling requires complete traceability to prevent mixing or misidentification of materials.
Excerpt: Unclear source and contents of extra materials in the warehouse.
View Details
Your facility is a warehouse that is undisclosed with the U.S FDA.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Material receipt and handling is directly affected as there is no system to document incoming materials or verify labels.
Excerpt: You failed to document the incoming receipt of these materials and perform a visual examination to ensure correct and complete labeling.
View Details
There is no quality unit oversight.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: The observation directly mentions failures in the receipt, storage, and distribution of materials, linking it to the material receipt and handling process type.
Excerpt: There is a failure to establish adequate current Good Manufacturing Practice (cGMP) controls and a functioning quality control unit for the receipt, storage and distribution of APIs, Intermediates, and raw materials.
View Details
Certificates of analysis from raw material suppliers are accepted in lieu of testing
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: The observation highlights the gap in material receipt and handling where CoAs are used without verification.
Excerpt: Certificates of analysis from raw material suppliers are accepted in lieu of testing each component for conformance.
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: Material Receipt and Handling processes are directly linked as failures stem from inadequate testing and validation of components upon receipt.
Excerpt: Performed at least one specific identity test on each incoming component as required and you lack confirmatory testing procedures.
View Details

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Go back

Material Receipt and Handling

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

Material Receipt and Handling

Overview

48
Form 483s Issued
9
483s converted to WL
53
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
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Demario L Walls
3
2
José E Melendez
3
0
Arsen Karapetyan
3
0
Christopher R Czajka
3
0
Alan M Barker
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The raw materials and quantities documented in the batch production records do not support the actual yields observed for the APIs produced at your firm.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: Effective material handling requires complete traceability to prevent mixing or misidentification of materials.
Excerpt: Unclear source and contents of extra materials in the warehouse.
View Details
Your facility is a warehouse that is undisclosed with the U.S FDA.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Material receipt and handling is directly affected as there is no system to document incoming materials or verify labels.
Excerpt: You failed to document the incoming receipt of these materials and perform a visual examination to ensure correct and complete labeling.
View Details
There is no quality unit oversight.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: The observation directly mentions failures in the receipt, storage, and distribution of materials, linking it to the material receipt and handling process type.
Excerpt: There is a failure to establish adequate current Good Manufacturing Practice (cGMP) controls and a functioning quality control unit for the receipt, storage and distribution of APIs, Intermediates, and raw materials.
View Details
Certificates of analysis from raw material suppliers are accepted in lieu of testing
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: The observation highlights the gap in material receipt and handling where CoAs are used without verification.
Excerpt: Certificates of analysis from raw material suppliers are accepted in lieu of testing each component for conformance.
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: Material Receipt and Handling processes are directly linked as failures stem from inadequate testing and validation of components upon receipt.
Excerpt: Performed at least one specific identity test on each incoming component as required and you lack confirmatory testing procedures.
View Details

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