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

Analytics Overview

69
Form 483s Issued
9
483s converted to WL
76
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
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
20 Mar 2026
Eosera, Inc.
Drugs
13 Mar 2026
Isorx Cyclotron Center
Drugs
10 Mar 2026
COSMETIC LABORATORY INC
Drugs
27 Feb 2026
Brio Pharmaceuticals Inc
Drugs

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
Margaret M Annes
3
1
TITLE/ COMPANY Issue Date Status Details
Written procedures are not followed for the receipt, storage and handling.
Bausch and Lomb Incorporated
20 Mar 2026 Normal Justification: The observation details failures in documenting arrivals and incorrect placement in storage, directly impacting material handling processes.
Excerpt: Failed to document and complete the Purchasing Notification of Missing Documents Form (SOP21-076 Form B).
View Details
Failure to reject any lot of drug product containers that did not meet the appropriate written specifications
Eosera, Inc.
20 Mar 2026 Normal Justification: Defective containers at receipt were not flagged or rejected, implicating the material handling process.
Excerpt: Failed to reject lot #(b) (4) of (b) (4) bottles after finding imperfections.
View Details
Control procedures fail to include adequate steps to ensure that manufacturers know the identity of each batch of material
Grifols Diagnostic Solutions
13 Mar 2026 Normal Justification: The control procedures did not verify the identity of batches, affecting Material Receipt and Handling.
Excerpt: A) The Quality Unit did not adequately ensure that the identity of each batch of incoming active pharmaceutical ingredients was determined before use in the manufacturing process.
View Details
You did not establish written procedures describing the identification of components
Isorx Cyclotron Center
13 Mar 2026 Normal Justification: Material receipt and handling directly affect identification and traceability of components, critical for compliance.
Excerpt: Your SOP does not address receiving the same product with the same lot number on a different day.
View Details
The quality control unit lacks the responsibility and authority to approve and reject all components.
COSMETIC LABORATORY INC
10 Mar 2026 Normal Justification: Subpotent raw materials were accepted and used possibly due to ineffective handling and testing protocols.
Excerpt: Your firm uses subpotent raw materials in the manufacture of your firm's OTC drug products.
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.

Material Receipt and Handling

Overview

69
Form 483s Issued
9
483s converted to WL
76
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
20 Mar 2026
Bausch and Lomb Incorporated
Drugs
20 Mar 2026
Eosera, Inc.
Drugs
13 Mar 2026
Isorx Cyclotron Center
Drugs
10 Mar 2026
COSMETIC LABORATORY INC
Drugs
27 Feb 2026
Brio Pharmaceuticals Inc
Drugs

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
Margaret M Annes
3
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written procedures are not followed for the receipt, storage and handling.
Bausch and Lomb Incorporated
20 Mar 2026 Normal Justification: The observation details failures in documenting arrivals and incorrect placement in storage, directly impacting material handling processes.
Excerpt: Failed to document and complete the Purchasing Notification of Missing Documents Form (SOP21-076 Form B).
View Details
Failure to reject any lot of drug product containers that did not meet the appropriate written specifications
Eosera, Inc.
20 Mar 2026 Normal Justification: Defective containers at receipt were not flagged or rejected, implicating the material handling process.
Excerpt: Failed to reject lot #(b) (4) of (b) (4) bottles after finding imperfections.
View Details
Control procedures fail to include adequate steps to ensure that manufacturers know the identity of each batch of material
Grifols Diagnostic Solutions
13 Mar 2026 Normal Justification: The control procedures did not verify the identity of batches, affecting Material Receipt and Handling.
Excerpt: A) The Quality Unit did not adequately ensure that the identity of each batch of incoming active pharmaceutical ingredients was determined before use in the manufacturing process.
View Details
You did not establish written procedures describing the identification of components
Isorx Cyclotron Center
13 Mar 2026 Normal Justification: Material receipt and handling directly affect identification and traceability of components, critical for compliance.
Excerpt: Your SOP does not address receiving the same product with the same lot number on a different day.
View Details
The quality control unit lacks the responsibility and authority to approve and reject all components.
COSMETIC LABORATORY INC
10 Mar 2026 Normal Justification: Subpotent raw materials were accepted and used possibly due to ineffective handling and testing protocols.
Excerpt: Your firm uses subpotent raw materials in the manufacture of your firm's OTC drug products.
View Details

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