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Sub System /
Sample Management
Sample Management
View Detailed Analysis

Analytics Overview

123
Form 483s Issued
8
483s converted to WL
158
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
15 May 2026
Mylan Laboratories Limited
Drugs
01 May 2026
Mixlab WI LLC
Drugs
08 Apr 2026
Reproductive Sciences Medical Center
Drugs
07 Apr 2026
Catalent Massachusetts, LLC
Drugs
26 Mar 2026
OneBlood, Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Irina Gaberman
22
0
David Carlson
11
0
Christy Osgood
11
0
Anthony N Onianwa
11
0
Kiya Hamilton
11
0
TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 1b: A sound and appropriate program for sampling, testing, and evaluating components
Not available
29 Jun 2026 Normal Justification: The issue relates directly to the need for robust sampling methods and procedures to effectively evaluate material quality.
Excerpt: Check the sampling plans to confirm that representative samples are collected and tested/examined to verify product quality.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Mylan Laboratories Limited
15 May 2026 Normal Justification: The lack of testing details for individual samples indicates significant sample management oversights.
Excerpt: Your worksheets had provision to record testing information for only sample out of samples.
View Details
Other Comments - During our review, we noted multiple prescriptions filled April 14, 2025, to June 30, 2025, from the same prescriber at a county humane society for two different animals
Mixlab WI LLC
01 May 2026 Normal Justification: The observation indicates an issue related to mismanagement or misuse of prescribed medicinal samples, which falls under improper Sample Management practices.
Excerpt: lack of patient-specific dosing instructions despite specific owner names being listed for both patients
View Details
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Reproductive Sciences Medical Center
08 Apr 2026 Normal Justification: Sample Management is linked as it involves oversight of potential donors being part of sample collection and eligibility verification.
Excerpt: Donors were not fully screened by a review of relevant medical records for risk factors.
View Details
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Reproductive Sciences Medical Center
08 Apr 2026 Normal Justification: Sample Management is linked as it involves oversight of potential donors being part of sample collection and eligibility verification.
Excerpt: Donors were not fully screened by a review of relevant medical records for risk factors.
View Details

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Sample Management

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

Sample Management

Overview

123
Form 483s Issued
8
483s converted to WL
158
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
15 May 2026
Mylan Laboratories Limited
Drugs
01 May 2026
Mixlab WI LLC
Drugs
08 Apr 2026
Reproductive Sciences Medical Center
Drugs
07 Apr 2026
Catalent Massachusetts, LLC
Drugs
26 Mar 2026
OneBlood, Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Irina Gaberman
22
0
David Carlson
11
0
Christy Osgood
11
0
Anthony N Onianwa
11
0
Kiya Hamilton
11
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
OBJECTIVE 1b: A sound and appropriate program for sampling, testing, and evaluating components
Not available
29 Jun 2026 Normal Justification: The issue relates directly to the need for robust sampling methods and procedures to effectively evaluate material quality.
Excerpt: Check the sampling plans to confirm that representative samples are collected and tested/examined to verify product quality.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Mylan Laboratories Limited
15 May 2026 Normal Justification: The lack of testing details for individual samples indicates significant sample management oversights.
Excerpt: Your worksheets had provision to record testing information for only sample out of samples.
View Details
Other Comments - During our review, we noted multiple prescriptions filled April 14, 2025, to June 30, 2025, from the same prescriber at a county humane society for two different animals
Mixlab WI LLC
01 May 2026 Normal Justification: The observation indicates an issue related to mismanagement or misuse of prescribed medicinal samples, which falls under improper Sample Management practices.
Excerpt: lack of patient-specific dosing instructions despite specific owner names being listed for both patients
View Details
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Reproductive Sciences Medical Center
08 Apr 2026 Normal Justification: Sample Management is linked as it involves oversight of potential donors being part of sample collection and eligibility verification.
Excerpt: Donors were not fully screened by a review of relevant medical records for risk factors.
View Details
Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.
Reproductive Sciences Medical Center
08 Apr 2026 Normal Justification: Sample Management is linked as it involves oversight of potential donors being part of sample collection and eligibility verification.
Excerpt: Donors were not fully screened by a review of relevant medical records for risk factors.
View Details

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