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Sub System /
HVAC
HVAC
View Detailed Analysis

Analytics Overview

20
Form 483s Issued
5
483s converted to WL
24
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
View Form 483
17 Feb 2026
PETNET Solutions Inc
Drugs
View Form 483
06 Jun 2025
Lonza Portsmouth, Inc.
Drugs
View Form 483
26 Jul 2024
Indoco Remedies Limited
Drugs
View Form 483
View Warning Letter
14 Jun 2024
Jubilant HollisterStier General Partnership
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
3
0
Rachael L Cook
3
3
Adam Ross Cooke
3
3
Brandy N Lepage
3
0
Annet R. Rajan
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: The observation highlights inadequate equipment design affecting HVAC function critical for maintaining sterile environments.
Excerpt: This design deficiency allows for the receiving tray of vials (capped and sealed) to protrude out, preventing the exit door from fully closing during filling operations.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Grifols Diagnostic Solutions		 13 Mar 2026 Normal Justification: HVAC is fundamental in controlling environmental conditions that affect contamination levels, linked to observation part C.
Excerpt: There was no control over the temperature and humidity levels in the aseptic processing area, which may contribute to microbial contamination.
View Details
You did not implement procedures to ensure that all equipment is suitable for its intended purposes
PETNET Solutions Inc		 17 Feb 2026 Normal Justification: The proximity and angle of the HVAC outlet directly influence air quality in the sterile LFH.
Excerpt: There is a design flaw in your ISO 5 Laminar Flow Hood (LFH) room...
View Details
Heating, ventilation, and air conditioning maintenance and controls are inadequate.
Lonza Portsmouth, Inc.		 06 Jun 2025 Normal Justification: The HVAC system's failure to maintain pressure differentials links directly to inadequate maintenance and control processes.
Excerpt: There have been repeated losses in differential pressure within the Grade areas for extended periods of time.
View Details
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair
Indoco Remedies Limited		 26 Jul 2024 Normal Justification: The observation describes air handling unit leaks affecting sterile environments, indicating deficiencies in HVAC system maintenance and monitoring.
Excerpt: These air handling units supply your sterile manufacturing cleanrooms. The leaks were located above cleanroom locations including, but not limited to, the Line (b) (4) corridor.
View Details

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HVAC

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

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HVAC

Overview

20
Form 483s Issued
5
483s converted to WL
24
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
View Form 483
17 Feb 2026
PETNET Solutions Inc
Drugs
View Form 483
06 Jun 2025
Lonza Portsmouth, Inc.
Drugs
View Form 483
26 Jul 2024
Indoco Remedies Limited
Drugs
View Form 483
View Warning Letter
14 Jun 2024
Jubilant HollisterStier General Partnership
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
3
0
Rachael L Cook
3
3
Adam Ross Cooke
3
3
Brandy N Lepage
3
0
Annet R. Rajan
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Imprimis NJOF, LLC		 18 Aug 2026 Normal Justification: The observation highlights inadequate equipment design affecting HVAC function critical for maintaining sterile environments.
Excerpt: This design deficiency allows for the receiving tray of vials (capped and sealed) to protrude out, preventing the exit door from fully closing during filling operations.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Grifols Diagnostic Solutions		 13 Mar 2026 Normal Justification: HVAC is fundamental in controlling environmental conditions that affect contamination levels, linked to observation part C.
Excerpt: There was no control over the temperature and humidity levels in the aseptic processing area, which may contribute to microbial contamination.
View Details
You did not implement procedures to ensure that all equipment is suitable for its intended purposes
PETNET Solutions Inc		 17 Feb 2026 Normal Justification: The proximity and angle of the HVAC outlet directly influence air quality in the sterile LFH.
Excerpt: There is a design flaw in your ISO 5 Laminar Flow Hood (LFH) room...
View Details
Heating, ventilation, and air conditioning maintenance and controls are inadequate.
Lonza Portsmouth, Inc.		 06 Jun 2025 Normal Justification: The HVAC system's failure to maintain pressure differentials links directly to inadequate maintenance and control processes.
Excerpt: There have been repeated losses in differential pressure within the Grade areas for extended periods of time.
View Details
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair
Indoco Remedies Limited		 26 Jul 2024 Normal Justification: The observation describes air handling unit leaks affecting sterile environments, indicating deficiencies in HVAC system maintenance and monitoring.
Excerpt: These air handling units supply your sterile manufacturing cleanrooms. The leaks were located above cleanroom locations including, but not limited to, the Line (b) (4) corridor.
View Details

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