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Sub System /
Calibration Management
Calibration Management
View Detailed Analysis

Analytics Overview

94
Form 483s Issued
7
483s converted to WL
101
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
19 Jun 2026
Eugia Steriles Private Limited
Drugs
View Form 483
29 May 2026
Shilpa Medicare Limited
Drugs
View Form 483
28 Apr 2026
Galaxy Medical Products LLC
Drugs
View Form 483
24 Apr 2026
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Drugs
View Form 483
20 Apr 2026
Paxeuticals LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Yvins Dezan
6
0
David Carlson
5
0
Christy Osgood
5
0
Kiya Hamilton
5
0
LaiMing Lee
5
0

Observations

View all 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 process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Calibration Management is linked because the observation highlights missing calibration records, critical to maintaining process accuracy.
Excerpt: There is no calibration record for such sensors involving the (b) (4) and (b) (4) built in as part of the stoppering process.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Calibration Management is linked because the observation highlights missing calibration records, critical to maintaining process accuracy.
Excerpt: There is no calibration record for such sensors involving the (b) (4) and (b) (4) built in as part of the stoppering process.
View Details
Written records are not always made of investigations into unexplained discrepancies
Shilpa Medicare Limited		 29 May 2026 Normal Justification: The failure to properly manage and assess the impact of calibration failings directly concerns the Calibration Management process.
Excerpt: You failed to conduct a thorough investigation and impact assessment on all the samples tested on the equipment since the last successful calibration to date.
View Details
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors
Galaxy Medical Products LLC		 28 Apr 2026 Normal Justification: Calibration Management is crucial here as the thermometer's calibration status directly impacted product quality assessments.
Excerpt: An out-of-calibration thermometer (Serial # (b) (4)) had exceeded its calibration due date by approximately four months.
View Details
Routine calibration, inspection, checking of automatic, mechanical, electronic equipment is not performed according
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.		 24 Apr 2026 Normal Justification: Calibration Management directly involves ensuring equipment accuracy and functionality, which failed here, compromising product quality.
Excerpt: Routine calibration, inspection, checking of automatic, mechanical, electronic equipment is not performed according to a written program.
View Details

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Calibration Management

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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Calibration Management

Overview

94
Form 483s Issued
7
483s converted to WL
101
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
19 Jun 2026
Eugia Steriles Private Limited
Drugs
View Form 483
29 May 2026
Shilpa Medicare Limited
Drugs
View Form 483
28 Apr 2026
Galaxy Medical Products LLC
Drugs
View Form 483
24 Apr 2026
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Drugs
View Form 483
20 Apr 2026
Paxeuticals LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Yvins Dezan
6
0
David Carlson
5
0
Christy Osgood
5
0
Kiya Hamilton
5
0
LaiMing Lee
5
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 process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Calibration Management is linked because the observation highlights missing calibration records, critical to maintaining process accuracy.
Excerpt: There is no calibration record for such sensors involving the (b) (4) and (b) (4) built in as part of the stoppering process.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process
Eugia Steriles Private Limited		 19 Jun 2026 Normal Justification: Calibration Management is linked because the observation highlights missing calibration records, critical to maintaining process accuracy.
Excerpt: There is no calibration record for such sensors involving the (b) (4) and (b) (4) built in as part of the stoppering process.
View Details
Written records are not always made of investigations into unexplained discrepancies
Shilpa Medicare Limited		 29 May 2026 Normal Justification: The failure to properly manage and assess the impact of calibration failings directly concerns the Calibration Management process.
Excerpt: You failed to conduct a thorough investigation and impact assessment on all the samples tested on the equipment since the last successful calibration to date.
View Details
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors
Galaxy Medical Products LLC		 28 Apr 2026 Normal Justification: Calibration Management is crucial here as the thermometer's calibration status directly impacted product quality assessments.
Excerpt: An out-of-calibration thermometer (Serial # (b) (4)) had exceeded its calibration due date by approximately four months.
View Details
Routine calibration, inspection, checking of automatic, mechanical, electronic equipment is not performed according
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.		 24 Apr 2026 Normal Justification: Calibration Management directly involves ensuring equipment accuracy and functionality, which failed here, compromising product quality.
Excerpt: Routine calibration, inspection, checking of automatic, mechanical, electronic equipment is not performed according to a written program.
View Details

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