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Sub System /
Distribution
Distribution
View Detailed Analysis

Analytics Overview

29
Form 483s Issued
2
483s converted to WL
33
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
13 Apr 2026
Scott & White Memorial Hospital
Drugs
View Form 483
11 Mar 2026
VET4U, LLC
Drugs
View Form 483
13 Feb 2026
Automated Ophthalmics, Inc.
Drugs
View Form 483
23 Jan 2026
Shimoga Chemicals
Drugs
View Form 483
16 Dec 2025
Bello Bio LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Garrad R. Poole
9
0
Irina Gaberman
6
0
Emily S. Mcgann
3
0
Laurissa S. Flowers
3
0
David A Moore
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written standard operating procedures including all steps to be followed in the distribution of blood
Scott & White Memorial Hospital		 13 Apr 2026 Normal Justification: Distribution is affected due to lacking instructions on emergency release form completion impacting procedural adherence.
Excerpt: The procedure does not adequately define necessary record keeping during the distribution of blood components.
View Details
Written standard operating procedures including all steps to be followed in the distribution of blood
Scott & White Memorial Hospital		 13 Apr 2026 Normal Justification: Distribution is affected due to lacking instructions on emergency release form completion impacting procedural adherence.
Excerpt: The procedure does not adequately define necessary record keeping during the distribution of blood components.
View Details
Your firm failed to comply with the requirements of section 582(c) of the FD&C Act, as amended by the DSCSA.
VET4U, LLC		 11 Mar 2026 Normal Justification: Products were distributed without the necessary transaction documents, a core issue in the "Distribution" process.
Excerpt: Your firm accepted and further distributed product purchased without first receiving the corresponding Transaction Statement and Transaction Information.
View Details
Product was not protected from alteration, contamination, or damage during processing, storage, handling, and distribution
Automated Ophthalmics, Inc.		 13 Feb 2026 Normal Justification: The observation indicates gaps in ensuring product quality during transportation, linked to Distribution control.
Excerpt: while the finished product is stored in the shipping storage awaiting shipping, or during shipping to the customer of the finished product.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Shimoga Chemicals		 23 Jan 2026 Normal Justification: Distribution process was affected as miscommunication led to inaccuracies in shipment records to the U.S. market.
Excerpt: Your firm could not readily provide accurate information about which batches were shipped to the U.S. market.
View Details

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Distribution

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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Distribution

Overview

29
Form 483s Issued
2
483s converted to WL
33
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
13 Apr 2026
Scott & White Memorial Hospital
Drugs
View Form 483
11 Mar 2026
VET4U, LLC
Drugs
View Form 483
13 Feb 2026
Automated Ophthalmics, Inc.
Drugs
View Form 483
23 Jan 2026
Shimoga Chemicals
Drugs
View Form 483
16 Dec 2025
Bello Bio LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Garrad R. Poole
9
0
Irina Gaberman
6
0
Emily S. Mcgann
3
0
Laurissa S. Flowers
3
0
David A Moore
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written standard operating procedures including all steps to be followed in the distribution of blood
Scott & White Memorial Hospital		 13 Apr 2026 Normal Justification: Distribution is affected due to lacking instructions on emergency release form completion impacting procedural adherence.
Excerpt: The procedure does not adequately define necessary record keeping during the distribution of blood components.
View Details
Written standard operating procedures including all steps to be followed in the distribution of blood
Scott & White Memorial Hospital		 13 Apr 2026 Normal Justification: Distribution is affected due to lacking instructions on emergency release form completion impacting procedural adherence.
Excerpt: The procedure does not adequately define necessary record keeping during the distribution of blood components.
View Details
Your firm failed to comply with the requirements of section 582(c) of the FD&C Act, as amended by the DSCSA.
VET4U, LLC		 11 Mar 2026 Normal Justification: Products were distributed without the necessary transaction documents, a core issue in the "Distribution" process.
Excerpt: Your firm accepted and further distributed product purchased without first receiving the corresponding Transaction Statement and Transaction Information.
View Details
Product was not protected from alteration, contamination, or damage during processing, storage, handling, and distribution
Automated Ophthalmics, Inc.		 13 Feb 2026 Normal Justification: The observation indicates gaps in ensuring product quality during transportation, linked to Distribution control.
Excerpt: while the finished product is stored in the shipping storage awaiting shipping, or during shipping to the customer of the finished product.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Shimoga Chemicals		 23 Jan 2026 Normal Justification: Distribution process was affected as miscommunication led to inaccuracies in shipment records to the U.S. market.
Excerpt: Your firm could not readily provide accurate information about which batches were shipped to the U.S. market.
View Details

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