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Pharmaceutical Quality Summit 2026
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Pharmaceutical Quality Summit 2026
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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

251
Form 483s Issued
47
483s converted to WL
513
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
05 Dec 2025
Ipca Laboratories Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
48
11
Anastasia M Shields
27
11
Taichun Qin
23
9
Sena G Dissmeyer
22
0
José E Melendez
18
9
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: Contamination control is critical in aseptic operations and interventions disruption in airflow can lead to contamination.
Excerpt: rely on a (b) (4) wait time for NVPC to return to normal without validated recovery times.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: The observation details lapses in sterile practices (e.g., contact with sterile equipment), directly implicating contamination control procedures.
Excerpt: Poor aseptic practices and inadequate glove monitoring were observed during review of CCTV recordings of sterile production.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Sato Pharmaceutical Co., Ltd.
05 Jan 2026 Normal Justification: The observation highlights flaws in controlling contamination due to inadequate airflow studies and equipment setup.
Excerpt: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
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: Failures in contamination control processes seen in environmental monitoring excursions and lack of follow-ups.
Excerpt: Unacceptable microorganism concentrations were reported... No root cause or corrective actions and preventative actions were documented.
View Details
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
19 Dec 2025 Normal Justification: The inadequate attire observed impacts contamination control in sterile settings, exposing drug products to contamination risks.
Excerpt: Your firm's pharmacy technicians...don scrubs worn from home, a disposable non-sterile gown, a single non-sterile hair net...
View Details

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Contamination Control

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

Contamination Control

Overview

251
Form 483s Issued
47
483s converted to WL
513
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
05 Dec 2025
Ipca Laboratories Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
48
11
Anastasia M Shields
27
11
Taichun Qin
23
9
Sena G Dissmeyer
22
0
José E Melendez
18
9

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: Contamination control is critical in aseptic operations and interventions disruption in airflow can lead to contamination.
Excerpt: rely on a (b) (4) wait time for NVPC to return to normal without validated recovery times.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: The observation details lapses in sterile practices (e.g., contact with sterile equipment), directly implicating contamination control procedures.
Excerpt: Poor aseptic practices and inadequate glove monitoring were observed during review of CCTV recordings of sterile production.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Sato Pharmaceutical Co., Ltd.
05 Jan 2026 Normal Justification: The observation highlights flaws in controlling contamination due to inadequate airflow studies and equipment setup.
Excerpt: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
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: Failures in contamination control processes seen in environmental monitoring excursions and lack of follow-ups.
Excerpt: Unacceptable microorganism concentrations were reported... No root cause or corrective actions and preventative actions were documented.
View Details
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
19 Dec 2025 Normal Justification: The inadequate attire observed impacts contamination control in sterile settings, exposing drug products to contamination risks.
Excerpt: Your firm's pharmacy technicians...don scrubs worn from home, a disposable non-sterile gown, a single non-sterile hair net...
View Details

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