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

Analytics Overview

98
Form 483s Issued
9
483s converted to WL
108
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
17 Apr 2026
Optimal Solution Labs LLC
Drugs
View Form 483
03 Apr 2026
Conroe Welding Supply, Inc
Drugs
View Form 483
27 Mar 2026
Q-Med AB
Drugs
View Form 483
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483
20 Mar 2026
Eosera, Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
6
0
Felix J Marrero
6
0
Garrad R. Poole
5
0
Emily B. Camire
4
0
Darren S Brown
3
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity
Optimal Solution Labs LLC		 17 Apr 2026 Normal Justification: Observation addresses inadequate handling procedures, directly aligning with risks in Material Receipt and Handling.
Excerpt: Your firm only performs color, odor, appearance and assay testing on incoming raw materials.
View Details
Your firm failed to perform required tests on bulk medical (b) (4) USP received for production.
Conroe Welding Supply, Inc		 03 Apr 2026 Normal Justification: Material Receipt and Handling is affected because the failure to test incoming materials suggests flaws in material acceptance procedures.
Excerpt: No testing was performed on any bulk lot of medical USP received from your supplier.
View Details
Your firm failed to perform required tests on bulk medical (b) (4) USP received for production.
Conroe Welding Supply, Inc		 03 Apr 2026 Normal Justification: Material Receipt and Handling is affected because the failure to test incoming materials suggests flaws in material acceptance procedures.
Excerpt: No testing was performed on any bulk lot of medical USP received from your supplier.
View Details
Components and raw materials are not adequately tested and approved prior to their use in manufacturing.
Q-Med AB		 27 Mar 2026 Normal Justification: Material handling issues evident from premature use of materials still labeled as quarantined.
Excerpt: Your firm failed to prevent the use of raw materials prior to their release from quarantine status.
View Details
Your firm's quality system is inadequate because the Quality Unit does not ensure control over material status and final product disposition
Q-Med AB		 27 Mar 2026 Normal Justification: Material Receipt and Handling is linked due to the improper control over material status prior to use, as highlighted by unreleased materials being manufactured.
Excerpt: Multiple (b) (4) DS batches have been partially released and manufactured into DP batches prior to being released by the Quality Unit.
View Details

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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.

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Material Receipt and Handling

Overview

98
Form 483s Issued
9
483s converted to WL
108
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
17 Apr 2026
Optimal Solution Labs LLC
Drugs
View Form 483
03 Apr 2026
Conroe Welding Supply, Inc
Drugs
View Form 483
27 Mar 2026
Q-Med AB
Drugs
View Form 483
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
View Form 483
20 Mar 2026
Eosera, Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
6
0
Felix J Marrero
6
0
Garrad R. Poole
5
0
Emily B. Camire
4
0
Darren S Brown
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity
Optimal Solution Labs LLC		 17 Apr 2026 Normal Justification: Observation addresses inadequate handling procedures, directly aligning with risks in Material Receipt and Handling.
Excerpt: Your firm only performs color, odor, appearance and assay testing on incoming raw materials.
View Details
Your firm failed to perform required tests on bulk medical (b) (4) USP received for production.
Conroe Welding Supply, Inc		 03 Apr 2026 Normal Justification: Material Receipt and Handling is affected because the failure to test incoming materials suggests flaws in material acceptance procedures.
Excerpt: No testing was performed on any bulk lot of medical USP received from your supplier.
View Details
Your firm failed to perform required tests on bulk medical (b) (4) USP received for production.
Conroe Welding Supply, Inc		 03 Apr 2026 Normal Justification: Material Receipt and Handling is affected because the failure to test incoming materials suggests flaws in material acceptance procedures.
Excerpt: No testing was performed on any bulk lot of medical USP received from your supplier.
View Details
Components and raw materials are not adequately tested and approved prior to their use in manufacturing.
Q-Med AB		 27 Mar 2026 Normal Justification: Material handling issues evident from premature use of materials still labeled as quarantined.
Excerpt: Your firm failed to prevent the use of raw materials prior to their release from quarantine status.
View Details
Your firm's quality system is inadequate because the Quality Unit does not ensure control over material status and final product disposition
Q-Med AB		 27 Mar 2026 Normal Justification: Material Receipt and Handling is linked due to the improper control over material status prior to use, as highlighted by unreleased materials being manufactured.
Excerpt: Multiple (b) (4) DS batches have been partially released and manufactured into DP batches prior to being released by the Quality Unit.
View Details

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