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Sub System /
Investigations
Investigations
View Detailed Analysis

Analytics Overview

148
Form 483s Issued
29
483s converted to WL
208
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
18
12
Justin A Boyd
17
5
Arsen Karapetyan
13
4
Pratik S Upadhyay
10
3
Anastasia M Shields
9
5

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 whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Investigations did not include all relevant batches, indicating gaps in systemic investigative procedures.
Excerpt: The investigation further concluded that, while troubleshooting the leak during the (4), the manufacturing operator adjusted (b) (4) without performing adequate measures.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: Inadequate investigations contribute to recurring contamination issues and compromise compliance.
Excerpt: Your firm failed to adequately investigate these media fill failures, to identify the root cause.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Observation revealed missing investigation protocols for discrepancies and monitoring results.
Excerpt: Your firm lacks written procedures for the management and handling of investigation of unexplained discrepancies.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The observation details a failure in thorough investigation protocols regarding particle presence and media fill failures.
Excerpt: The deviation investigations have failed to categorize types of visible particles or perform identification of particles.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited		 21 Nov 2025 Normal Justification: Observation highlights a critical failure in conducting required HHAs when OOS results are detected.
Excerpt: There was no Health Hazard Assessment (HHA) performed for the out of acceptance limit for (b)(4) impurity.
View Details

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Investigations

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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Investigations

Overview

148
Form 483s Issued
29
483s converted to WL
208
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483
21 Nov 2025
Pharmathen International S.A.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
18
12
Justin A Boyd
17
5
Arsen Karapetyan
13
4
Pratik S Upadhyay
10
3
Anastasia M Shields
9
5

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 whether or not the batch has been already distributed.
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: Investigations did not include all relevant batches, indicating gaps in systemic investigative procedures.
Excerpt: The investigation further concluded that, while troubleshooting the leak during the (4), the manufacturing operator adjusted (b) (4) without performing adequate measures.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: Inadequate investigations contribute to recurring contamination issues and compromise compliance.
Excerpt: Your firm failed to adequately investigate these media fill failures, to identify the root cause.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Observation revealed missing investigation protocols for discrepancies and monitoring results.
Excerpt: Your firm lacks written procedures for the management and handling of investigation of unexplained discrepancies.
View Details
There is a failure to thoroughly review any unexplained discrepancy
Pharmathen International S.A.		 21 Nov 2025 Normal Justification: The observation details a failure in thorough investigation protocols regarding particle presence and media fill failures.
Excerpt: The deviation investigations have failed to categorize types of visible particles or perform identification of particles.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited		 21 Nov 2025 Normal Justification: Observation highlights a critical failure in conducting required HHAs when OOS results are detected.
Excerpt: There was no Health Hazard Assessment (HHA) performed for the out of acceptance limit for (b)(4) impurity.
View Details

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