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Sub System /
Calibration Management
Calibration Management
View Detailed Analysis

Analytics Overview

38
Form 483s Issued
7
483s converted to WL
42
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
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
27 May 2025
Samsung Biologics Co., Ltd.
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
06 Jan 2025
Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Teresa I Navas
3
0
José E Melendez
3
0
Edmund F Mrak
3
1
Gavin T Cua
2
0
Jamirya S Weatherly
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: The calibration process failed due to inappropriate equipment usage, affecting measurement accuracy.
Excerpt: Calibration was performed using a scale that did not have the sensitivity (nearest thousandths) to measure 10 microliters (uL) ± 0.12 (nearest hundredths) accurately and precisely.
View Details
Your firm failed to appropriately install and qualify equipment used in the production of Active Pharmaceutical Ingredients
Not available		 01 Aug 2025 Normal Justification: Calibration Management is central as calibration certificates for critical testing equipment were expired, affecting product quality.
Excerpt: The high-performance liquid chromatography (HPLC) system used for the analysis of API purity was observed to have calibration certificates expired.
View Details
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release and (b) (4) testing are deficient.
Samsung Biologics Co., Ltd.		 27 May 2025 Normal Justification: Equipment error linked to outdated calibration standards impacted test results, indicating Calibration Management issues.
Excerpt: Delays in requalification of the reference standard and equipment error.
View Details
Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: The issue directly relates to how the calibration of the equipment is managed, affecting measurement accuracy.
Excerpt: The balance with Equipment Id. MF-BS-11 is not calibrated within the range of use.
View Details
Automatic or electronic equipment, including computers or related systems, are not routinely calibrated, inspected, or checked according to written programs
Suzhou Suncadia Biopharmaceuticals Co. Ltd.		 06 Jan 2025 Normal Justification: Calibration Management directly relates to the failure to routinely calibrate and verify electronic equipment for proper performance.
Excerpt: Software settings for (b)(4) Non-viable Particle (NVP) monitoring systems were not verified to ensure proper performance after system upgrades.
View Details

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Go back

Calibration Management

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

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Calibration Management

Overview

38
Form 483s Issued
7
483s converted to WL
42
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
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
27 May 2025
Samsung Biologics Co., Ltd.
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
06 Jan 2025
Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Teresa I Navas
3
0
José E Melendez
3
0
Edmund F Mrak
3
1
Gavin T Cua
2
0
Jamirya S Weatherly
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: The calibration process failed due to inappropriate equipment usage, affecting measurement accuracy.
Excerpt: Calibration was performed using a scale that did not have the sensitivity (nearest thousandths) to measure 10 microliters (uL) ± 0.12 (nearest hundredths) accurately and precisely.
View Details
Your firm failed to appropriately install and qualify equipment used in the production of Active Pharmaceutical Ingredients
Not available		 01 Aug 2025 Normal Justification: Calibration Management is central as calibration certificates for critical testing equipment were expired, affecting product quality.
Excerpt: The high-performance liquid chromatography (HPLC) system used for the analysis of API purity was observed to have calibration certificates expired.
View Details
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release and (b) (4) testing are deficient.
Samsung Biologics Co., Ltd.		 27 May 2025 Normal Justification: Equipment error linked to outdated calibration standards impacted test results, indicating Calibration Management issues.
Excerpt: Delays in requalification of the reference standard and equipment error.
View Details
Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: The issue directly relates to how the calibration of the equipment is managed, affecting measurement accuracy.
Excerpt: The balance with Equipment Id. MF-BS-11 is not calibrated within the range of use.
View Details
Automatic or electronic equipment, including computers or related systems, are not routinely calibrated, inspected, or checked according to written programs
Suzhou Suncadia Biopharmaceuticals Co. Ltd.		 06 Jan 2025 Normal Justification: Calibration Management directly relates to the failure to routinely calibrate and verify electronic equipment for proper performance.
Excerpt: Software settings for (b)(4) Non-viable Particle (NVP) monitoring systems were not verified to ensure proper performance after system upgrades.
View Details

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