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Sub System /
Calibration Management
Calibration Management
View Detailed Analysis

Analytics Overview

68
Form 483s Issued
7
483s converted to WL
73
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
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
20 Mar 2026
Eosera, Inc.
Drugs
10 Mar 2026
COSMETIC LABORATORY INC
Drugs
27 Feb 2026
Gasco Industrial Corp.
Drugs
24 Feb 2026
RayzeBio, Inc
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
5
0
LaiMing Lee
5
0
Christy Osgood
5
0
David Carlson
5
0
Li Wang
5
0
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Charles River Laboratories, Inc.
27 Mar 2026 Normal Justification: Calibration ensures test accuracy and compliance.
Excerpt: A (b)(4) weight with a calibration due date of 03/12/2026 was observed...
View Details
Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Eosera, Inc.
20 Mar 2026 Normal Justification: Calibration Management ensures equipment function correctly, impacting product quality. Overdue calibration violates compliance and risks product efficacy.
Excerpt: I observed that your firm had not calibrated the in-line (b) (4) used to test (b) (4) in the manufacture of OTC drug products.
View Details
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
COSMETIC LABORATORY INC
10 Mar 2026 Normal Justification: Observation highlights deficiencies in Calibration Management; scales were not calibrated per SOP, affecting operation reliability.
Excerpt: Your firm failed to perform calibrations of your firm’s weighing scales. On 03/09/2026, your firm was unable to provide evidence...
View Details
Laboratory records are deficient in that they do not include the initials and signature of the second person
Gasco Industrial Corp.
27 Feb 2026 Normal Justification: Calibration discrepancies can affect product quality, revealing procedural gaps.
Excerpt: Calibration record for pH meters not verified for accuracy during operation period.
View Details
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient
Gasco Industrial Corp.
27 Feb 2026 Normal Justification: Calibration Management is fundamentally related as the instruments were used without ensuring calibration, impacting measurement accuracy.
Excerpt: Written calibration procedures do not include specific directions, schedules, limits for accuracy and precision.
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.

Calibration Management

Overview

68
Form 483s Issued
7
483s converted to WL
73
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
27 Mar 2026
Charles River Laboratories, Inc.
Drugs
20 Mar 2026
Eosera, Inc.
Drugs
10 Mar 2026
COSMETIC LABORATORY INC
Drugs
27 Feb 2026
Gasco Industrial Corp.
Drugs
24 Feb 2026
RayzeBio, Inc
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
5
0
LaiMing Lee
5
0
Christy Osgood
5
0
David Carlson
5
0
Li Wang
5
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Charles River Laboratories, Inc.
27 Mar 2026 Normal Justification: Calibration ensures test accuracy and compliance.
Excerpt: A (b)(4) weight with a calibration due date of 03/12/2026 was observed...
View Details
Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Eosera, Inc.
20 Mar 2026 Normal Justification: Calibration Management ensures equipment function correctly, impacting product quality. Overdue calibration violates compliance and risks product efficacy.
Excerpt: I observed that your firm had not calibrated the in-line (b) (4) used to test (b) (4) in the manufacture of OTC drug products.
View Details
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
COSMETIC LABORATORY INC
10 Mar 2026 Normal Justification: Observation highlights deficiencies in Calibration Management; scales were not calibrated per SOP, affecting operation reliability.
Excerpt: Your firm failed to perform calibrations of your firm’s weighing scales. On 03/09/2026, your firm was unable to provide evidence...
View Details
Laboratory records are deficient in that they do not include the initials and signature of the second person
Gasco Industrial Corp.
27 Feb 2026 Normal Justification: Calibration discrepancies can affect product quality, revealing procedural gaps.
Excerpt: Calibration record for pH meters not verified for accuracy during operation period.
View Details
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient
Gasco Industrial Corp.
27 Feb 2026 Normal Justification: Calibration Management is fundamentally related as the instruments were used without ensuring calibration, impacting measurement accuracy.
Excerpt: Written calibration procedures do not include specific directions, schedules, limits for accuracy and precision.
View Details

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