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Sub System /
Process Control
Process Control
View Detailed Analysis

Analytics Overview

158
Form 483s Issued
15
483s converted to WL
197
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
View Form 483
05 May 2026
Zydus Lifesciences Limited
Drugs
View Form 483
17 Apr 2026
Optimal Solution Labs LLC
Drugs
View Form 483
27 Mar 2026
Fujifilm Diosynth Biotechnologies USA Inc.
Drugs
View Form 483
19 Mar 2026
Veterinary Pharmacy Corporation
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
15
1
Christy Osgood
11
0
Kiya Hamilton
11
0
David Carlson
11
0
LaiMing Lee
11
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess are not fully followed
Ultragenyx Pharmaceutical, Inc		 19 Aug 2026 Normal Justification: Process Control is linked as it ensures product quality by enforcing procedure adherence, crucial for maintaining drug specifications.
Excerpt: are not fully followed.
View Details
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: This observation indicates a deficiency in the control and documentation of process parameters critical to maintaining product quality, hence directly tied to Process Control.
Excerpt: Specifically, the air flow visualization study for the (b)(4) Filing Line ... was not conducted in accordance with a written protocol.
View Details
The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
Optimal Solution Labs LLC		 17 Apr 2026 Normal Justification: Process Control is responsible for ensuring product quality. Inadequate sampling indicates failure in process oversight.
Excerpt: Failed to take in process samples of production batches to evaluate uniformity.
View Details
Your procedure for testing (b) (4) after use in your drug substance processing is inadequate in that it does not limit
Fujifilm Diosynth Biotechnologies USA Inc.		 27 Mar 2026 Normal Justification: Process Control is linked due to the necessity of clearly defined limits for effective monitoring and prevention of failures.
Excerpt: your written procedure for testing process (b) (4), SOP-01444...has a limit of (b) (4) (b) (4) tests before contacting the area manager.
View Details
Deviation from the procedural requirements of a decree of injunction.
Veterinary Pharmacy Corporation		 19 Mar 2026 Normal Justification: Process Control is crucial as deviation from required controls for endotoxin testing relates directly to product safety standards.
Excerpt: you do not test each lot of product for pyrogens/endotoxins.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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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

158
Form 483s Issued
15
483s converted to WL
197
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
19 Aug 2026
Ultragenyx Pharmaceutical, Inc
Drugs
View Form 483
05 May 2026
Zydus Lifesciences Limited
Drugs
View Form 483
17 Apr 2026
Optimal Solution Labs LLC
Drugs
View Form 483
27 Mar 2026
Fujifilm Diosynth Biotechnologies USA Inc.
Drugs
View Form 483
19 Mar 2026
Veterinary Pharmacy Corporation
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
15
1
Christy Osgood
11
0
Kiya Hamilton
11
0
David Carlson
11
0
LaiMing Lee
11
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess are not fully followed
Ultragenyx Pharmaceutical, Inc		 19 Aug 2026 Normal Justification: Process Control is linked as it ensures product quality by enforcing procedure adherence, crucial for maintaining drug specifications.
Excerpt: are not fully followed.
View Details
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: This observation indicates a deficiency in the control and documentation of process parameters critical to maintaining product quality, hence directly tied to Process Control.
Excerpt: Specifically, the air flow visualization study for the (b)(4) Filing Line ... was not conducted in accordance with a written protocol.
View Details
The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
Optimal Solution Labs LLC		 17 Apr 2026 Normal Justification: Process Control is responsible for ensuring product quality. Inadequate sampling indicates failure in process oversight.
Excerpt: Failed to take in process samples of production batches to evaluate uniformity.
View Details
Your procedure for testing (b) (4) after use in your drug substance processing is inadequate in that it does not limit
Fujifilm Diosynth Biotechnologies USA Inc.		 27 Mar 2026 Normal Justification: Process Control is linked due to the necessity of clearly defined limits for effective monitoring and prevention of failures.
Excerpt: your written procedure for testing process (b) (4), SOP-01444...has a limit of (b) (4) (b) (4) tests before contacting the area manager.
View Details
Deviation from the procedural requirements of a decree of injunction.
Veterinary Pharmacy Corporation		 19 Mar 2026 Normal Justification: Process Control is crucial as deviation from required controls for endotoxin testing relates directly to product safety standards.
Excerpt: you do not test each lot of product for pyrogens/endotoxins.
View Details

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