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Sub System /
CAPA
CAPA
View Detailed Analysis

Analytics Overview

173
Form 483s Issued
19
483s converted to WL
198
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
19 Jun 2026
Eugia Steriles Private Limited
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
10 Apr 2026
AstraZeneca AB
Drugs
View Form 483
09 Apr 2026
Lantheus Medical Imaging, Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
8
3
Arsen Karapetyan
7
1
Laura Fontan
6
0
Creighton T Tuzon
6
0
Travis S Bradley
6
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: CAPAs did not address root causes properly; procedures remained misaligned with operational realities.
Excerpt: CAPA implemented are not commensurate with the scope of the identified root causes
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: CAPA inadequately addressed extending investigations to other batches, a critical component of preventing recurrence.
Excerpt: CAPA was opened... to extend investigation; however, it was limited in scope addressing only identified issues.
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: CAPA inadequately addressed extending investigations to other batches, a critical component of preventing recurrence.
Excerpt: CAPA was opened... to extend investigation; however, it was limited in scope addressing only identified issues.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Alkem Laboratories Limited		 01 May 2026 Normal Justification: Observation highlights repeated inadequacies due to ineffective root cause identification and CAPA implementation.
Excerpt: CAPA taken is inadequate to determine the risk to the drug products sold into the US market.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
AstraZeneca AB		 10 Apr 2026 Normal Justification: CAPA processes are essential to ensure consistent follow-through on resolving identified problems permanently.
Excerpt: Despite the four times, no corrective and preventive action (CAPA) was initiated.
View Details

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CAPA

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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CAPA

Overview

173
Form 483s Issued
19
483s converted to WL
198
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
19 Jun 2026
Eugia Steriles Private Limited
Drugs
View Form 483
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
10 Apr 2026
AstraZeneca AB
Drugs
View Form 483
09 Apr 2026
Lantheus Medical Imaging, Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
8
3
Arsen Karapetyan
7
1
Laura Fontan
6
0
Creighton T Tuzon
6
0
Travis S Bradley
6
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: CAPAs did not address root causes properly; procedures remained misaligned with operational realities.
Excerpt: CAPA implemented are not commensurate with the scope of the identified root causes
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: CAPA inadequately addressed extending investigations to other batches, a critical component of preventing recurrence.
Excerpt: CAPA was opened... to extend investigation; however, it was limited in scope addressing only identified issues.
View Details
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: CAPA inadequately addressed extending investigations to other batches, a critical component of preventing recurrence.
Excerpt: CAPA was opened... to extend investigation; however, it was limited in scope addressing only identified issues.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Alkem Laboratories Limited		 01 May 2026 Normal Justification: Observation highlights repeated inadequacies due to ineffective root cause identification and CAPA implementation.
Excerpt: CAPA taken is inadequate to determine the risk to the drug products sold into the US market.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
AstraZeneca AB		 10 Apr 2026 Normal Justification: CAPA processes are essential to ensure consistent follow-through on resolving identified problems permanently.
Excerpt: Despite the four times, no corrective and preventive action (CAPA) was initiated.
View Details

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