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Sub System /

Training Management

View Detailed Analysis

Analytics Overview

140

Form 483s Issued

483s converted to WL

199

Total Observation

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

29 Jun 2026

Vascular Solutions, LLC

Drugs

View Form 483

23 Mar 2026

Dr. J Skinclinic, Inc

Drugs

View Form 483

13 Mar 2026

Isorx Cyclotron Center

Drugs

View Form 483

06 Mar 2026

PETNET Solutions, Inc.

Drugs

View Form 483

27 Feb 2026

Brio Pharmaceuticals Inc

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Sena G Dissmeyer

Pratik S Upadhyay

José E Melendez

Logan T Williams

Saleem A Akhtar

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	Details
Pre-License Inspection #1 Vascular Solutions, LLC	29 Jun 2026	Normal	Justification: The issuance of Form 483 with numerous observations highlights potential training inadequacies. Excerpt: Pre-License Inspection #1 with 14 observations View Details
Employees are not given training in the particular operations they perform Dr. J Skinclinic, Inc	23 Mar 2026	Normal	Justification: Training Management is crucial for ensuring personnel are competent in their roles and that records reflect their training status. Excerpt: SOP-103 'Employee Training Program,' Section 4.3, not properly implemented; missing CGMP training records for senior management. View Details
You lack personnel with the necessary training and experience to perform their assigned functions. Isorx Cyclotron Center	13 Mar 2026	Normal	Justification: Training deficiencies are directly linked to Training Management failures, affecting GMP compliance. Excerpt: Training on standard operating procedures is not documented. A review of the training record for the assistant cyclotron operator lacked documentation. View Details
You did not follow written quality assurance procedures. PETNET Solutions, Inc.	06 Mar 2026	Normal	Justification: Adequate training ensures that personnel understand and adhere to critical procedures. Excerpt: The procedure instructs operators to (b) (4), observed (b) (4) fingertip onto media surface. View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed. Brio Pharmaceuticals Inc	27 Feb 2026	Normal	Justification: Training Management: The observation highlights non-compliance with cGMP training, directly under Training Management per SOP. Excerpt: Your firm did not provide current Good Manufacturing Practice (cGMP) training to employees in 2024 and 2025. View Details

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Training Management

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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Overview

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