Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST. Save Your Seat
Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST Save Your Seat
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Sub System /
Area Qualification
Area Qualification
View Detailed Analysis

Analytics Overview

24
Form 483s Issued
6
483s converted to WL
29
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
15 May 2025
Apothecary Pharma LLC
Drugs
04 Apr 2025
PQ Pharmacy LLC
Drugs
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs
28 Feb 2025
Palmetto Isotopes, LLC
Drugs
21 Feb 2025
Meds For Vets
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Xiaohui Shen
3
1
Taichun Qin
3
0
Justine Tomasso
2
0
Jessica P Mcalister
2
1
Demario L Walls
2
0
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Apothecary Pharma LLC
15 May 2025 Normal Justification: Area Qualification impacts were noted where procedural adherence within ISO 5 environments failed.
Excerpt: Operators rest forearms on ISO 5 bench and lean their heads into the hood.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Apothecary Pharma LLC
15 May 2025 Normal Justification: Area Qualification is key here as the failure pertains to overlooking of certification reports necessary for cleanroom validation.
Excerpt: Failure to review Certification Report Control ID #4049-339748-64877 for cleanroom validation.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
PQ Pharmacy LLC
04 Apr 2025 Normal Justification: Area Qualification is impacted by improper execution and review of environmental conditions.
Excerpt: Smoke Studies conducted in September 2024 appear to exhibit turbulence in the Non-hazardous Cleanroom 1 ISO-7 area.
View Details
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
03 Apr 2025 Normal Justification: Area Qualification is essential due to the use of unqualified spaces for sterile production, increasing contamination risks.
Excerpt: Unclassified room that contains potential contaminants; room also serves as an office.
View Details
Lack of a certified ISO-5 classified area for sterile compounding
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
03 Apr 2025 Normal Justification: Area Qualification directly relates to the need for ISO-5 classified environments for sterility control.
Excerpt: Your firm fills syringes intended for subcutaneous injection by withdrawing sterile solution from vials on a benchtop table, located in an unclassified room.
View Details

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Area Qualification

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

Area Qualification

Overview

24
Form 483s Issued
6
483s converted to WL
29
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
15 May 2025
Apothecary Pharma LLC
Drugs
04 Apr 2025
PQ Pharmacy LLC
Drugs
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs
28 Feb 2025
Palmetto Isotopes, LLC
Drugs
21 Feb 2025
Meds For Vets
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Xiaohui Shen
3
1
Taichun Qin
3
0
Justine Tomasso
2
0
Jessica P Mcalister
2
1
Demario L Walls
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Apothecary Pharma LLC
15 May 2025 Normal Justification: Area Qualification impacts were noted where procedural adherence within ISO 5 environments failed.
Excerpt: Operators rest forearms on ISO 5 bench and lean their heads into the hood.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Apothecary Pharma LLC
15 May 2025 Normal Justification: Area Qualification is key here as the failure pertains to overlooking of certification reports necessary for cleanroom validation.
Excerpt: Failure to review Certification Report Control ID #4049-339748-64877 for cleanroom validation.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
PQ Pharmacy LLC
04 Apr 2025 Normal Justification: Area Qualification is impacted by improper execution and review of environmental conditions.
Excerpt: Smoke Studies conducted in September 2024 appear to exhibit turbulence in the Non-hazardous Cleanroom 1 ISO-7 area.
View Details
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
03 Apr 2025 Normal Justification: Area Qualification is essential due to the use of unqualified spaces for sterile production, increasing contamination risks.
Excerpt: Unclassified room that contains potential contaminants; room also serves as an office.
View Details
Lack of a certified ISO-5 classified area for sterile compounding
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
03 Apr 2025 Normal Justification: Area Qualification directly relates to the need for ISO-5 classified environments for sterility control.
Excerpt: Your firm fills syringes intended for subcutaneous injection by withdrawing sterile solution from vials on a benchtop table, located in an unclassified room.
View Details

Frequently Asked Questions

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