Equipment Qualification

Analytics Overview

112

Form 483s Issued

483s converted to WL

139

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

15 May 2026

Emcure Pharmaceuticals Limited

Drugs

View Form 483

05 May 2026

Zydus Lifesciences Limited

Drugs

View Form 483

20 Mar 2026

Bora Pharmaceuticals Injectables Inc

Drugs

View Form 483

20 Mar 2026

Eosera, Inc.

Drugs

View Form 483

18 Mar 2026

Cardinal Health 414, LLC

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Brandy N Lepage

José E Melendez

Brentley S Pittman

Demario L Walls

Jessica S Estriplet

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use Emcure Pharmaceuticals Limited	15 May 2026	Normal	Justification: The observation highlights deficiencies in Equipment Qualification, affecting product quality directly through suboptimal equipment performance. Excerpt: Your firm has not conducted any protocol-driven Performance Qualification (PQ) Studies with pre-approved acceptance criteria. 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: Equipment Qualification is affected as the airflow visualization study directly pertains to validating the aseptic conditions around equipment use. Excerpt: The air flow visualization study ... was not conducted in accordance with a written protocol. View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. Zydus Lifesciences Limited	05 May 2026	Normal	Justification: Qualified equipment is essential for ensuring consistent sterility in drug product manufacturing. Excerpt: Equipment is used to aseptically fill (b)(4), which is intended for the U.S. market. View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Zydus Lifesciences Limited	05 May 2026	Normal	Justification: HEPA filter positioning and parameters should be defined during equipment qualification to maintain valid aseptic conditions. Excerpt: HEPA filters in the critical area that aseptic filling transpires were not defined during equipment qualification studies. View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed Bora Pharmaceuticals Injectables Inc	20 Mar 2026	Normal	Justification: Observation highlighted insufficient assurance in equipment qualification as a reason for compliance failure. Excerpt: Your firm lacks adequate assurance that critical equipment and systems used in the manufacture of sterile drug products are properly qualified. View Details

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Equipment Qualification

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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