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Sub System /
Document Management
Document Management
View Detailed Analysis

Analytics Overview

414
Form 483s Issued
26
483s converted to WL
620
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
19 Aug 2026
Ultragenyx Pharmaceutical, Inc
Drugs
19 Jun 2026
Eugia Steriles Private Limited
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
19 May 2026
Lonza Bend Inc.
Drugs
15 May 2026
Mylan Laboratories Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Irina Gaberman
60
0
Creighton T Tuzon
25
0
Christy Osgood
18
0
David Carlson
18
0
José E Melendez
18
12
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Ultragenyx Pharmaceutical, Inc
19 Aug 2026 Normal Justification: Document management failure may result in outdated or missed procedural guidelines within the quality control unit.
Excerpt: The responsibilities and procedures applicable to the quality control unit are not fully followed.
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Lack of SOPs for various trials and missing justifications indicate weak document management processes.
Excerpt: There is no standard operating procedure or written justification for the following trials...
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Lack of SOPs for various trials and missing justifications indicate weak document management processes.
Excerpt: There is no standard operating procedure or written justification for the following trials...
View Details
Your firm failed to exercise controls over computerized manufacturing equipment
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Record-keeping failures stem from poor documentation practices, leading to non-traceability of manufacturing processes.
Excerpt: Batch manufacturing records fail to consistently document the specific recipes used.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Lonza Bend Inc.
19 May 2026 Normal Justification: Missing documentation instances like unsupervised visual verifications indicate flawed document management processes.
Excerpt: Operator...performed the visual verification of that gasket...documentation did not indicate...
View Details

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Document Management

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

Document Management

Overview

414
Form 483s Issued
26
483s converted to WL
620
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
19 Aug 2026
Ultragenyx Pharmaceutical, Inc
Drugs
19 Jun 2026
Eugia Steriles Private Limited
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
19 May 2026
Lonza Bend Inc.
Drugs
15 May 2026
Mylan Laboratories Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Irina Gaberman
60
0
Creighton T Tuzon
25
0
Christy Osgood
18
0
David Carlson
18
0
José E Melendez
18
12

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Ultragenyx Pharmaceutical, Inc
19 Aug 2026 Normal Justification: Document management failure may result in outdated or missed procedural guidelines within the quality control unit.
Excerpt: The responsibilities and procedures applicable to the quality control unit are not fully followed.
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Lack of SOPs for various trials and missing justifications indicate weak document management processes.
Excerpt: There is no standard operating procedure or written justification for the following trials...
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Lack of SOPs for various trials and missing justifications indicate weak document management processes.
Excerpt: There is no standard operating procedure or written justification for the following trials...
View Details
Your firm failed to exercise controls over computerized manufacturing equipment
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Record-keeping failures stem from poor documentation practices, leading to non-traceability of manufacturing processes.
Excerpt: Batch manufacturing records fail to consistently document the specific recipes used.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Lonza Bend Inc.
19 May 2026 Normal Justification: Missing documentation instances like unsupervised visual verifications indicate flawed document management processes.
Excerpt: Operator...performed the visual verification of that gasket...documentation did not indicate...
View Details

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