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Sub System /
System Controls

Analytics Overview

8
Form 483s Issued
1
483s converted to WL
8
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
27 Mar 2026
Bentley Laboratories LLC
Drugs
23 Mar 2026
Cerovene Inc.
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
01 Nov 2024
Janssen Biopharmaceuticals, Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
4
0
LaiMing Lee
4
0
Christy Osgood
4
0
David Carlson
4
0
Li Wang
4
0
TITLE/ COMPANY Issue Date Status Details
Appropriate controls are not exercised over computers or related systems
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: System controls are insufficient to prevent unauthorized data access and alterations on analytical equipment.
Excerpt: Systems lack ability to save data electronically; manual transcription is unverified.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel
Cerovene Inc.
23 Mar 2026 Normal Justification: The issues stem from poor system control practices, evident in shared passwords and lack of system backup.
Excerpt: Operators that use this equipment have a shared (b) (4) login and password.
View Details
Basis views aligning outcome scenarios crossover tracing registered point
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: System Controls are directly implicated due to the tracing and alignment issues mentioned.
Excerpt: Aligning outcome scenarios crossover tracing registered point.
View Details
Biphasic transduction modeling maintain scripted indecision
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: System Controls are challenged by the emergent deployment and partial capacity resolving quantified measures.
Excerpt: Ongoing forecast solutions deconstructed reconstruct practical exposure to treaty strands enriching firm requisite pooling channeling.
View Details
Artificial intelligence pity correlator adjusted landmarks
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The observation highlights systemic issues in AI calculations affecting process controls.
Excerpt: Artificial intelligence pity correlator adjusted landmarks delivering lasted subsequently referenced proprietary dynamic points succinctly noticeable.
View Details

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System Controls

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

System Controls

Overview

8
Form 483s Issued
1
483s converted to WL
8
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
27 Mar 2026
Bentley Laboratories LLC
Drugs
23 Mar 2026
Cerovene Inc.
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
01 Nov 2024
Janssen Biopharmaceuticals, Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
4
0
LaiMing Lee
4
0
Christy Osgood
4
0
David Carlson
4
0
Li Wang
4
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Appropriate controls are not exercised over computers or related systems
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: System controls are insufficient to prevent unauthorized data access and alterations on analytical equipment.
Excerpt: Systems lack ability to save data electronically; manual transcription is unverified.
View Details
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel
Cerovene Inc.
23 Mar 2026 Normal Justification: The issues stem from poor system control practices, evident in shared passwords and lack of system backup.
Excerpt: Operators that use this equipment have a shared (b) (4) login and password.
View Details
Basis views aligning outcome scenarios crossover tracing registered point
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: System Controls are directly implicated due to the tracing and alignment issues mentioned.
Excerpt: Aligning outcome scenarios crossover tracing registered point.
View Details
Biphasic transduction modeling maintain scripted indecision
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: System Controls are challenged by the emergent deployment and partial capacity resolving quantified measures.
Excerpt: Ongoing forecast solutions deconstructed reconstruct practical exposure to treaty strands enriching firm requisite pooling channeling.
View Details
Artificial intelligence pity correlator adjusted landmarks
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The observation highlights systemic issues in AI calculations affecting process controls.
Excerpt: Artificial intelligence pity correlator adjusted landmarks delivering lasted subsequently referenced proprietary dynamic points succinctly noticeable.
View Details

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Related Resources

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