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Sub System /
Calibration Management
Calibration Management
View Detailed Analysis

Analytics Overview

34
Form 483s Issued
6
483s converted to WL
38
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
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
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
26 Jul 2024
Biocon Biologics Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Edmund F Mrak
3
1
Teresa I Navas
3
0
Jacob G Lutz
2
0
Alan L Truong
2
0
Gavin T Cua
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
You have not established Laboratory controls that include the establishment of scientifically sound and appropriate specifications
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: Expired calibration references indicate insufficient control over calibration practices, risking data veracity.
Excerpt: Utilized (b) (4) Lot # (b) (4) with (b) (4) expiry date from 09/30/2024 to calibrate.
View Details
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Calibration Management ensures instruments provide accurate results. Failures noted in the observation indicate deficiencies in maintaining calibrated equipment per set requirements.
Excerpt: The reproducibility test in the calibration certificates for these balances do not meet the required specifications to ensure suitability.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products are not maintained in a manner to prevent malfunctions that would alter the drug product quality.
Biocon Biologics Limited		 26 Jul 2024 Normal Justification: Preventive maintenance records missing tracer information for instruments used in verification processes implicate weaknesses in calibration management.
Excerpt: Preventive maintenance records... do not identify the instruments used for verifying laminar flow and pressures.
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

34
Form 483s Issued
6
483s converted to WL
38
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
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
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
26 Jul 2024
Biocon Biologics Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Edmund F Mrak
3
1
Teresa I Navas
3
0
Jacob G Lutz
2
0
Alan L Truong
2
0
Gavin T Cua
2
0

Key Observations

TITLE/ COMPANY Issue Date Status 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
You have not established Laboratory controls that include the establishment of scientifically sound and appropriate specifications
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: Expired calibration references indicate insufficient control over calibration practices, risking data veracity.
Excerpt: Utilized (b) (4) Lot # (b) (4) with (b) (4) expiry date from 09/30/2024 to calibrate.
View Details
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Calibration Management ensures instruments provide accurate results. Failures noted in the observation indicate deficiencies in maintaining calibrated equipment per set requirements.
Excerpt: The reproducibility test in the calibration certificates for these balances do not meet the required specifications to ensure suitability.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products are not maintained in a manner to prevent malfunctions that would alter the drug product quality.
Biocon Biologics Limited		 26 Jul 2024 Normal Justification: Preventive maintenance records missing tracer information for instruments used in verification processes implicate weaknesses in calibration management.
Excerpt: Preventive maintenance records... do not identify the instruments used for verifying laminar flow and pressures.
View Details

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