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Sub System /
Equipment Qualification
Equipment Qualification
View Detailed Analysis

Analytics Overview

158
Form 483s Issued
13
483s converted to WL
194
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
19 Jun 2026
Eugia Steriles Private Limited
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Lizaida Perez
14
0
Brandy N Lepage
11
0
Brentley S Pittman
10
0
Unnee Ranjan
10
0
Carl Perez
6
0
TITLE/ COMPANY Issue Date Status Details
Procedures for the maintenance of equipment used in the manufacture and testing of FAYUVI are not followed.
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: Equipment Qualification is linked, ensuring autoclave's reliable performance post-maintenance is critical for sterility.
Excerpt: Potentially lead to equipment malfunction and impact the sterility assurance of aseptically filled products.
View Details
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Equipment qualification is essential to verify proper equipment functionality. Omission of loaded-temperature mapping violates industry standards.
Excerpt: Your firm has not performed temperature mapping under the worst-case conditions for your critical equipment during equipment qualification.
View Details
The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: The failure in Performance Qualification approval directly links to Equipment Qualification process issues.
Excerpt: Approving a PQ that structurally excluded the confirmed worst-case location identified by the firm’s own temperature mapping.
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Missing equipment logs highlight a critical gap in ensuring equipment is qualified and used appropriately.
Excerpt: No equipment logbook in place as per SOP ...
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Missing equipment logs highlight a critical gap in ensuring equipment is qualified and used appropriately.
Excerpt: No equipment logbook in place as per SOP ...
View Details

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Equipment Qualification

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

Equipment Qualification

Overview

158
Form 483s Issued
13
483s converted to WL
194
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
19 Jun 2026
Eugia Steriles Private Limited
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Lizaida Perez
14
0
Brandy N Lepage
11
0
Brentley S Pittman
10
0
Unnee Ranjan
10
0
Carl Perez
6
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures for the maintenance of equipment used in the manufacture and testing of FAYUVI are not followed.
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: Equipment Qualification is linked, ensuring autoclave's reliable performance post-maintenance is critical for sterility.
Excerpt: Potentially lead to equipment malfunction and impact the sterility assurance of aseptically filled products.
View Details
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Equipment qualification is essential to verify proper equipment functionality. Omission of loaded-temperature mapping violates industry standards.
Excerpt: Your firm has not performed temperature mapping under the worst-case conditions for your critical equipment during equipment qualification.
View Details
The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: The failure in Performance Qualification approval directly links to Equipment Qualification process issues.
Excerpt: Approving a PQ that structurally excluded the confirmed worst-case location identified by the firm’s own temperature mapping.
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Missing equipment logs highlight a critical gap in ensuring equipment is qualified and used appropriately.
Excerpt: No equipment logbook in place as per SOP ...
View Details
The responsibilities and procedures applicable to the quality control unit are not writing or fully followed.
Eugia Steriles Private Limited
19 Jun 2026 Normal Justification: Missing equipment logs highlight a critical gap in ensuring equipment is qualified and used appropriately.
Excerpt: No equipment logbook in place as per SOP ...
View Details

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