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Sub System /

Document Management

View Detailed Analysis

Analytics Overview

229

Form 483s Issued

483s converted to WL

326

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

20 May 2026

Strides Pharma Science Ltd.

Drugs

View Form 483

01 May 2026

Mixlab WI LLC

Drugs

View Form 483

27 Mar 2026

Bentley Laboratories LLC

Drugs

View Form 483

23 Mar 2026

Cerovene Inc.

Drugs

View Form 483

23 Mar 2026

Dr. J Skinclinic, Inc

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Kiya Hamilton

Christy Osgood

David Carlson

José E Melendez

LaiMing Lee

Observations

View all Observations

TITLE/ COMPANY	Issue Date	Status	Details
Your firm failed to exercise controls over computerized manufacturing equipment Strides Pharma Science Ltd.	20 May 2026	Normal	Justification: Record-keeping failures stem from poor documentation practices, leading to non-traceability of manufacturing processes. Excerpt: Batch manufacturing records fail to consistently document the specific recipes used. View Details
Copies of Approved or Indexed Products: Mixlab WI LLC	01 May 2026	Normal	Justification: Efficient and complete documentation is critical for transparency and accountability in pharmaceutical processes. Excerpt: Records for the prescriber’s medical rationale do not describe why the approved drug is unacceptable or unsafe. View Details
Written procedures are not established and followed for the cleaning and maintenance of equipment Bentley Laboratories LLC	27 Mar 2026	Normal	Justification: Failure to document cleaning contact times correlates with poor Document Management practices. Excerpt: During a walkthrough on 03/17/2026, no documentation to show contact time maintained... View Details
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. Dr. J Skinclinic, Inc	23 Mar 2026	Normal	Justification: The issue arises from improper documentation practices mandated by SOP-102, directly linked to document management. Excerpt: Your employees failed to follow your firms SOP, SOP number: SOP-102, SOP Title: Good Documentation Practices. View Details
Established lab control mechanisms are not followed Cerovene Inc.	23 Mar 2026	Normal	Justification: Documentation lapses are evident from missing preparation dates, violating procedures for managing laboratory records and standards maintenance. Excerpt: 7 flasks lacked a preparation date and expired stock standards were used. View Details

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Document Management

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

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