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Sub System /
Material Storage and Control
Material Storage and Control
View Detailed Analysis

Analytics Overview

60
Form 483s Issued
7
483s converted to WL
79
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
13 Mar 2026
Isorx Cyclotron Center
Drugs
10 Mar 2026
Hospira, Inc.
Drugs
06 Mar 2026
IsoTis OrthoBiologics, Inc.
Drugs
05 Mar 2026
Accra-Pac, Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Brianna R. Scott
6
0
Albert L. Nguyen
6
0
Courtney R. A. Ingalsbe
6
0
Constance-Richard-Math
5
0
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: Incorrect placement of materials in storage highlights deficiencies in material control protocols.
Excerpt: Materials not placed in specified locations as per inventory management system.
View Details
You did not review production records to determine whether errors had occurred.
Isorx Cyclotron Center
13 Mar 2026 Normal Justification: The observation pertains to the mismanagement and erroneous use of expired materials, fundamental to material storage and control.
Excerpt: The firm lacks an effective material management and inventory tracking system to prevent mix-ups of expired materials.
View Details
b. (b) (4) was observed with
Hospira, Inc.
10 Mar 2026 Normal Justification: The observation indicates frequent leaks from material lines, directly associated with material handling and control.
Excerpt: b. (b) (4) line to an open bucket, along with locations.
View Details
You did not ensure that establishment(s) that by contract, agreement or arrangement, perform manufacturing steps for you were in compliance with applicable CGTP requirements prior to the initiation
IsoTis OrthoBiologics, Inc.
06 Mar 2026 Normal Justification: Material Storage and Control is directly impacted as improper temperature management was identified.
Excerpt: Your firm failed to require at least (b) (4) of your consignees to maintain, record, and periodically review storage temperature records.
View Details
All compounding and storage containers used during the production of a batch of drug product is not properly identified
Accra-Pac, Inc.
05 Mar 2026 Normal Justification: Material Storage and Control is crucial in preventing mix-ups and ensuring traceability within the manufacturing process.
Excerpt: The tankers displayed only tank numbers and lacked labels or placards indicating their receiving status and contents.
View Details

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Material Storage and Control

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Material Storage and Control

Overview

60
Form 483s Issued
7
483s converted to WL
79
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
13 Mar 2026
Isorx Cyclotron Center
Drugs
10 Mar 2026
Hospira, Inc.
Drugs
06 Mar 2026
IsoTis OrthoBiologics, Inc.
Drugs
05 Mar 2026
Accra-Pac, Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Brianna R. Scott
6
0
Albert L. Nguyen
6
0
Courtney R. A. Ingalsbe
6
0
Constance-Richard-Math
5
0

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: Incorrect placement of materials in storage highlights deficiencies in material control protocols.
Excerpt: Materials not placed in specified locations as per inventory management system.
View Details
You did not review production records to determine whether errors had occurred.
Isorx Cyclotron Center
13 Mar 2026 Normal Justification: The observation pertains to the mismanagement and erroneous use of expired materials, fundamental to material storage and control.
Excerpt: The firm lacks an effective material management and inventory tracking system to prevent mix-ups of expired materials.
View Details
b. (b) (4) was observed with
Hospira, Inc.
10 Mar 2026 Normal Justification: The observation indicates frequent leaks from material lines, directly associated with material handling and control.
Excerpt: b. (b) (4) line to an open bucket, along with locations.
View Details
You did not ensure that establishment(s) that by contract, agreement or arrangement, perform manufacturing steps for you were in compliance with applicable CGTP requirements prior to the initiation
IsoTis OrthoBiologics, Inc.
06 Mar 2026 Normal Justification: Material Storage and Control is directly impacted as improper temperature management was identified.
Excerpt: Your firm failed to require at least (b) (4) of your consignees to maintain, record, and periodically review storage temperature records.
View Details
All compounding and storage containers used during the production of a batch of drug product is not properly identified
Accra-Pac, Inc.
05 Mar 2026 Normal Justification: Material Storage and Control is crucial in preventing mix-ups and ensuring traceability within the manufacturing process.
Excerpt: The tankers displayed only tank numbers and lacked labels or placards indicating their receiving status and contents.
View Details

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