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Sub System /
Process Validation
Process Validation
View Detailed Analysis

Analytics Overview

156
Form 483s Issued
21
483s converted to WL
192
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
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
07 Aug 2026
Neeyaan LLC
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
05 May 2026
Zydus Lifesciences Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
21
0
Christy Osgood
21
0
Kiya Hamilton
21
0
David Carlson
21
0
Li Wang
21
0
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Process validation involves ensuring all aspects of production meet standards; deficiencies in AFV and media fill undermine this validation.
Excerpt: No formal study reports or supporting documentation were available for review for either study.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Observation highlights insufficient sterilization validation, fundamental to process validation ensuring aseptic environments.
Excerpt: Procedures designed to prevent microbiological contamination did not include adequate validation of the aseptic and sterilization process.
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.
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Inadequate Process Validation highlighted by missing (b)(4) compatibility studies during critical qualification phase.
Excerpt: The firm does not have a procedure governing the process for (b)(4) compatibility studies and has not conducted (b)(4) compatibility studies.
View Details
Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity
Neeyaan LLC
07 Aug 2026 Normal Justification: Process validation is essential for verifying that manufacturing processes achieve consistent product quality. The observation highlights a failure in conducting such validation.
Excerpt: You failed to demonstrate your drug manufacturing processes are adequately validated. Additionally, you manufactured and released (b) (4) lots of (b) (4) USP tablets in 2025 intended for export. Your firm stated that no process validation was conducted for this product.
View Details
OBJECTIVE 1e: The proposed commercial process and manufacturing batch record, including instructions
Not available
29 Jun 2026 Normal Justification: Process validation is essential for establishing the feasibility of manufacturing operations using scientifically justified data. The observation notes a lack of sufficient validation studies.
Excerpt: At a minimum, data from Stage I process validation should be available. Evaluate Stage I process validation development studies and knowledge gained.
View Details

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Process Validation

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Process Validation

Overview

156
Form 483s Issued
21
483s converted to WL
192
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
07 Aug 2026
Neeyaan LLC
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
05 May 2026
Zydus Lifesciences Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
21
0
Christy Osgood
21
0
Kiya Hamilton
21
0
David Carlson
21
0
Li Wang
21
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Process validation involves ensuring all aspects of production meet standards; deficiencies in AFV and media fill undermine this validation.
Excerpt: No formal study reports or supporting documentation were available for review for either study.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Observation highlights insufficient sterilization validation, fundamental to process validation ensuring aseptic environments.
Excerpt: Procedures designed to prevent microbiological contamination did not include adequate validation of the aseptic and sterilization process.
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.
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Inadequate Process Validation highlighted by missing (b)(4) compatibility studies during critical qualification phase.
Excerpt: The firm does not have a procedure governing the process for (b)(4) compatibility studies and has not conducted (b)(4) compatibility studies.
View Details
Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity
Neeyaan LLC
07 Aug 2026 Normal Justification: Process validation is essential for verifying that manufacturing processes achieve consistent product quality. The observation highlights a failure in conducting such validation.
Excerpt: You failed to demonstrate your drug manufacturing processes are adequately validated. Additionally, you manufactured and released (b) (4) lots of (b) (4) USP tablets in 2025 intended for export. Your firm stated that no process validation was conducted for this product.
View Details
OBJECTIVE 1e: The proposed commercial process and manufacturing batch record, including instructions
Not available
29 Jun 2026 Normal Justification: Process validation is essential for establishing the feasibility of manufacturing operations using scientifically justified data. The observation notes a lack of sufficient validation studies.
Excerpt: At a minimum, data from Stage I process validation should be available. Evaluate Stage I process validation development studies and knowledge gained.
View Details

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