Process Control

Analytics Overview

133

Form 483s Issued

483s converted to WL

172

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

05 May 2026

Zydus Lifesciences Limited

Drugs

View Form 483

27 Mar 2026

Fujifilm Diosynth Biotechnologies USA Inc.

Drugs

View Form 483

13 Mar 2026

Isorx Cyclotron Center

Drugs

View Form 483

10 Mar 2026

Hospira, Inc.

Drugs

View Form 483

27 Feb 2026

Gasco Industrial Corp.

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Justin A Boyd

Kiya Hamilton

Christy Osgood

David Carlson

LaiMing Lee

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	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
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
Permitted variations in the amount of component necessary are not reasonable and not specified in the master production and control records. Isorx Cyclotron Center	13 Mar 2026	Normal	Justification: Action limits are critical for ensuring batch consistency; their absence leads to process control issues. Excerpt: Your master production and control records did not include a statement of action limits on radiochemical yield. View Details
On 05 March 2026, observed during the production of lot Hospira, Inc.	10 Mar 2026	Normal	Justification: The observation directly relates to maintaining process parameters within specified limits during filling operations. Excerpt: You failed to optimize the filling process in mitigation of the observed attribute. View Details
Failure to establish process controls designed to assure that the drug products manufactured have the identity, strength, quality, and purity Hospira, Inc.	10 Mar 2026	Normal	Justification: The observed lack of process controls directly impacted the ability to maintain drug quality during production. Excerpt: You failed to (b)(4) sterilize the equipment and assemble the equipment to the (b) (4) in a manner... 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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Overview

Trends

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Process Control

Overview

133

Form 483s Issued

483s converted to WL

172

Total Observation

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

05 May 2026

Zydus Lifesciences Limited

Drugs

View Form 483

27 Mar 2026

Fujifilm Diosynth Biotechnologies USA Inc.

Drugs

View Form 483

13 Mar 2026

Isorx Cyclotron Center

Drugs

View Form 483

10 Mar 2026

Hospira, Inc.

Drugs

View Form 483

27 Feb 2026

Gasco Industrial Corp.

Drugs

View Form 483

Top FDA Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Justin A Boyd

Kiya Hamilton

Christy Osgood

David Carlson

LaiMing Lee

Key Observations

TITLE/ COMPANY	Issue Date	Status	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
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
Permitted variations in the amount of component necessary are not reasonable and not specified in the master production and control records. Isorx Cyclotron Center	13 Mar 2026	Normal	Justification: Action limits are critical for ensuring batch consistency; their absence leads to process control issues. Excerpt: Your master production and control records did not include a statement of action limits on radiochemical yield. View Details
On 05 March 2026, observed during the production of lot Hospira, Inc.	10 Mar 2026	Normal	Justification: The observation directly relates to maintaining process parameters within specified limits during filling operations. Excerpt: You failed to optimize the filling process in mitigation of the observed attribute. View Details
Failure to establish process controls designed to assure that the drug products manufactured have the identity, strength, quality, and purity Hospira, Inc.	10 Mar 2026	Normal	Justification: The observed lack of process controls directly impacted the ability to maintain drug quality during production. Excerpt: You failed to (b)(4) sterilize the equipment and assemble the equipment to the (b) (4) in a manner... View Details

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Analytics Overview

Analytics Overview

Recent Form 483s & Warning Letters

Top Investigators

Observations

Prepare Better for FDA Audits with FDA Tracker

Process Control

Process Control

Overview

FDA Trends

Recent Form 483s & Warning Letters

Top FDA Investigators

Key Observations

Frequently Asked Questions

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