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Sub System /
Contamination Control
Contamination Control
View Detailed Analysis

Analytics Overview

307
Form 483s Issued
47
483s converted to WL
621
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
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
05 May 2026
Zydus Lifesciences Limited
Drugs
08 Apr 2026
Pharmaneek Inc
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
50
11
Anastasia M Shields
29
11
Taichun Qin
23
9
Sena G Dissmeyer
23
0
Brandy N Lepage
18
0
TITLE/ COMPANY Issue Date Status Details
There is a lack of written procedures assigning responsibility
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Effective contamination control is essential for maintaining cleanroom classification and ensuring product safety and sterility.
Excerpt: Your firm acknowledged that scheduling...could permit up to (b) (4) between cleaning events.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: The observation explicitly mentions compromised contamination control infrastructure impacting sterile environments.
Excerpt: The shared personnel and material pathway through the visual inspection and labeling room... deficiencies in contamination control infrastructure.
View Details
There is a failure to thoroughly review any unexplained discrepancy
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Contamination control procedures failed to prevent sterility failures, highlighting gaps in the existing strategy.
Excerpt: The integrity of the contamination control strategy was inadequate, posing a risk to sterility assurance.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Effective contamination control is vital to maintaining aseptic conditions during drug production.
Excerpt: Rapid movements and failure to adhere to cleaning protocols were observed in the cleanroom environment.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Failures repeatedly found in sterility tests and contamination events indicate lapses in contamination control.
Excerpt: failed to conduct an adequate investigation to determine the root cause of the recovery of Bacillus cabrialesii
View Details

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Contamination Control

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

Contamination Control

Overview

307
Form 483s Issued
47
483s converted to WL
621
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
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
05 May 2026
Zydus Lifesciences Limited
Drugs
08 Apr 2026
Pharmaneek Inc
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
50
11
Anastasia M Shields
29
11
Taichun Qin
23
9
Sena G Dissmeyer
23
0
Brandy N Lepage
18
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a lack of written procedures assigning responsibility
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Effective contamination control is essential for maintaining cleanroom classification and ensuring product safety and sterility.
Excerpt: Your firm acknowledged that scheduling...could permit up to (b) (4) between cleaning events.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: The observation explicitly mentions compromised contamination control infrastructure impacting sterile environments.
Excerpt: The shared personnel and material pathway through the visual inspection and labeling room... deficiencies in contamination control infrastructure.
View Details
There is a failure to thoroughly review any unexplained discrepancy
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Contamination control procedures failed to prevent sterility failures, highlighting gaps in the existing strategy.
Excerpt: The integrity of the contamination control strategy was inadequate, posing a risk to sterility assurance.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Effective contamination control is vital to maintaining aseptic conditions during drug production.
Excerpt: Rapid movements and failure to adhere to cleaning protocols were observed in the cleanroom environment.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: Failures repeatedly found in sterility tests and contamination events indicate lapses in contamination control.
Excerpt: failed to conduct an adequate investigation to determine the root cause of the recovery of Bacillus cabrialesii
View Details

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Related Resources

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