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Sub System /
Deviations
Deviations
View Detailed Analysis

Analytics Overview

124
Form 483s Issued
12
483s converted to WL
149
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
View Form 483
10 Mar 2026
Hospira, Inc.
Drugs
View Form 483
06 Mar 2026
Aurorium LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
6
0
Laurel Beer
5
0
Carl Perez
5
0
Joseph A Piechocki
5
3
Patty P Kaewussdangkul
5
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: Actionable measures for deviation investigations were neglected, showing deviations management issues.
Excerpt: The Quality Unit did not implement Corrective Action and Preventative Actions that were commensurate with the root causes identified in Deviation Investigations.
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: Deviation handling is central as the process inadequately ensures resolution before progressing to further product inspection or release.
Excerpt: a deviation is initiated, and a (b)(4) (b)(4) inspection of the remaining accepted units is conducted in tandem with the deviation investigation.
View Details
Deviations from written production and process control procedures are not recorded and justified.
Alkem Laboratories Limited		 01 May 2026 Normal Justification: The observation highlights unrecorded and unjustified deviations, pointing to flaws in deviation management processes.
Excerpt: Deviations from written production and process control procedures are not recorded and justified.
View Details
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
Alkem Laboratories Limited		 01 May 2026 Normal Justification: Deviation handling failures indicate a breakdown in the systems capturing alterations from standard conditions.
Excerpt: No manufacturing deviations or documentation in the executed batch records were available for these failures.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Charles River Laboratories, Inc.		 27 Mar 2026 Normal Justification: Correct classification ensures proper risk management.
Excerpt: Deviation DEV-03248 was classified as minor, despite potential impact...
View Details

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Deviations

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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Deviations

Overview

124
Form 483s Issued
12
483s converted to WL
149
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
View Form 483
10 Mar 2026
Hospira, Inc.
Drugs
View Form 483
06 Mar 2026
Aurorium LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Arsen Karapetyan
6
0
Laurel Beer
5
0
Carl Perez
5
0
Joseph A Piechocki
5
3
Patty P Kaewussdangkul
5
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: Actionable measures for deviation investigations were neglected, showing deviations management issues.
Excerpt: The Quality Unit did not implement Corrective Action and Preventative Actions that were commensurate with the root causes identified in Deviation Investigations.
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: Deviation handling is central as the process inadequately ensures resolution before progressing to further product inspection or release.
Excerpt: a deviation is initiated, and a (b)(4) (b)(4) inspection of the remaining accepted units is conducted in tandem with the deviation investigation.
View Details
Deviations from written production and process control procedures are not recorded and justified.
Alkem Laboratories Limited		 01 May 2026 Normal Justification: The observation highlights unrecorded and unjustified deviations, pointing to flaws in deviation management processes.
Excerpt: Deviations from written production and process control procedures are not recorded and justified.
View Details
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
Alkem Laboratories Limited		 01 May 2026 Normal Justification: Deviation handling failures indicate a breakdown in the systems capturing alterations from standard conditions.
Excerpt: No manufacturing deviations or documentation in the executed batch records were available for these failures.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Charles River Laboratories, Inc.		 27 Mar 2026 Normal Justification: Correct classification ensures proper risk management.
Excerpt: Deviation DEV-03248 was classified as minor, despite potential impact...
View Details

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