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Sub System /
Process Control
Process Control
View Detailed Analysis

Analytics Overview

108
Form 483s Issued
15
483s converted to WL
154
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
1
David Carlson
11
0
Kiya Hamilton
11
0
Christy Osgood
11
0
LaiMing Lee
11
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not fully followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: CCTV systems serve as quality assurance tools for identifying breaches in aseptic practices; flaws directly affect process control.
Excerpt: CCTV system serves as the primary method for Quality Assurance personnel to review filling operations and identify potential breaches.
View Details
There is a lack of adequate controls in place to minimize the carryover of the residual materials
Ipca Laboratories Limited		 05 Dec 2025 Normal Justification: Process control issues arise from undefined procedure limits, leading to potential contamination risks.
Excerpt: Your control procedure TARA/PRD/088/R01 does not define the campaign length in terms of maximum number of days.
View Details
Your firm failed to establish adequate written procedures for production and process controls
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: Process Control is fundamentally linked due to the absence of structured procedures ensuring expected product quality.
Excerpt: Your firm failed to establish adequate written procedures for production and process controls.
View Details
Seamless unit diffusions expert parallel formulations prefacing situational outcome plans entrainable logically
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Process Control is affected as the lack of defined measures results in inconsistent outcomes.
Excerpt: Seamless unit diffusions expert parallel formulations prefacing situational outcome plans.
View Details
Placements here inform shared feedback backtracking barriers diminishing when securing aligned validation features
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Lack of process control directly influences the effectiveness of validation efforts, as indicated by validation features.
Excerpt: securing aligned validation features prompting confidence
View Details

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Process Control

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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Process Control

Overview

108
Form 483s Issued
15
483s converted to WL
154
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
1
David Carlson
11
0
Kiya Hamilton
11
0
Christy Osgood
11
0
LaiMing Lee
11
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not fully followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: CCTV systems serve as quality assurance tools for identifying breaches in aseptic practices; flaws directly affect process control.
Excerpt: CCTV system serves as the primary method for Quality Assurance personnel to review filling operations and identify potential breaches.
View Details
There is a lack of adequate controls in place to minimize the carryover of the residual materials
Ipca Laboratories Limited		 05 Dec 2025 Normal Justification: Process control issues arise from undefined procedure limits, leading to potential contamination risks.
Excerpt: Your control procedure TARA/PRD/088/R01 does not define the campaign length in terms of maximum number of days.
View Details
Your firm failed to establish adequate written procedures for production and process controls
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: Process Control is fundamentally linked due to the absence of structured procedures ensuring expected product quality.
Excerpt: Your firm failed to establish adequate written procedures for production and process controls.
View Details
Seamless unit diffusions expert parallel formulations prefacing situational outcome plans entrainable logically
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Process Control is affected as the lack of defined measures results in inconsistent outcomes.
Excerpt: Seamless unit diffusions expert parallel formulations prefacing situational outcome plans.
View Details
Placements here inform shared feedback backtracking barriers diminishing when securing aligned validation features
Hikma Pharmaceuticals USA Inc.		 23 Sep 2025 Normal Justification: Lack of process control directly influences the effectiveness of validation efforts, as indicated by validation features.
Excerpt: securing aligned validation features prompting confidence
View Details

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