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Sub System /
Penicillin Contamination
Penicillin Contamination
View Detailed Analysis

Analytics Overview

8
Form 483s Issued
0
483s converted to WL
10
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
29 Apr 2025
East Orange VA Medical Center
Drugs
View Form 483
15 Oct 2023
Acme Pharmaceuticals Inc.
Drugs
View Form 483
15 Oct 2023
Acme Pharmaceuticals Ltd.
Drugs
View Form 483
05 Oct 2023
XYZ Food Production Co.
Drugs
View Form 483
15 Sep 2023
ABC Pharmaceuticals
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
5
0
John Doe
5
0
Justin A Boyd
2
0
John Smith
1
0
Investigator Jane Smith
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination
East Orange VA Medical Center		 29 Apr 2025 Normal Justification: Directly relates to the handling of penicillin, requiring specific measures to prevent contamination as noted in the observation text.
Excerpt: Your firm does not have policies in place to deactivate Penicillin and Beta Lactam products after production.
View Details
The firm failed to establish and follow appropriate written procedures
Acme Pharmaceuticals Ltd.		 15 Oct 2023 Normal Justification: This observation directly pertains to 'Penicillin Contamination' due to inadequate procedures preventing cross-contact of penicillin with non-penicillin products.
Excerpt: The warehouse where penicillin is stored was not physically separated... The HVAC system did not have a dedicated air handling unit.
View Details
Failure to wear appropriate protective apparel during production activities
Acme Pharmaceuticals Inc.		 15 Oct 2023 Normal Justification: Penicillin contamination risks are heightened when proper protective apparel is not used, as described in the observation.
Excerpt: Operators in the cleanroom were observed not wearing sterile coveralls and gloves, contrary to SOP number SOP-123.
View Details
There are inadequate control systems in place to prevent the cross-contamination of drug products.
XYZ Food Production Co.		 05 Oct 2023 Normal Justification: The observation directly mentions the risk of cross-contamination in products handled in shared spaces, linked to penicillin contamination.
Excerpt: highlighted that shared production spaces were not properly disinfected and cause containment was inadequate between the production of penicillin-based and non-penicillin products.
View Details
Your firm failed to implement adequate measures to prevent cross-contamination
XYZ Pharmaceuticals		 15 Sep 2023 Normal Justification: Cross-contamination of penicillin products with non-penicillin products directly relates to 'Penicillin Contamination'.
Excerpt: Your firm failed to implement adequate measures to prevent cross-contamination of penicillin products with non-penicillin products.
View Details

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Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
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Penicillin Contamination

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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Penicillin Contamination

Overview

8
Form 483s Issued
0
483s converted to WL
10
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
29 Apr 2025
East Orange VA Medical Center
Drugs
View Form 483
15 Oct 2023
Acme Pharmaceuticals Inc.
Drugs
View Form 483
15 Oct 2023
Acme Pharmaceuticals Ltd.
Drugs
View Form 483
05 Oct 2023
XYZ Food Production Co.
Drugs
View Form 483
15 Sep 2023
ABC Pharmaceuticals
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
5
0
John Doe
5
0
Justin A Boyd
2
0
John Smith
1
0
Investigator Jane Smith
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination
East Orange VA Medical Center		 29 Apr 2025 Normal Justification: Directly relates to the handling of penicillin, requiring specific measures to prevent contamination as noted in the observation text.
Excerpt: Your firm does not have policies in place to deactivate Penicillin and Beta Lactam products after production.
View Details
The firm failed to establish and follow appropriate written procedures
Acme Pharmaceuticals Ltd.		 15 Oct 2023 Normal Justification: This observation directly pertains to 'Penicillin Contamination' due to inadequate procedures preventing cross-contact of penicillin with non-penicillin products.
Excerpt: The warehouse where penicillin is stored was not physically separated... The HVAC system did not have a dedicated air handling unit.
View Details
Failure to wear appropriate protective apparel during production activities
Acme Pharmaceuticals Inc.		 15 Oct 2023 Normal Justification: Penicillin contamination risks are heightened when proper protective apparel is not used, as described in the observation.
Excerpt: Operators in the cleanroom were observed not wearing sterile coveralls and gloves, contrary to SOP number SOP-123.
View Details
There are inadequate control systems in place to prevent the cross-contamination of drug products.
XYZ Food Production Co.		 05 Oct 2023 Normal Justification: The observation directly mentions the risk of cross-contamination in products handled in shared spaces, linked to penicillin contamination.
Excerpt: highlighted that shared production spaces were not properly disinfected and cause containment was inadequate between the production of penicillin-based and non-penicillin products.
View Details
Your firm failed to implement adequate measures to prevent cross-contamination
XYZ Pharmaceuticals		 15 Sep 2023 Normal Justification: Cross-contamination of penicillin products with non-penicillin products directly relates to 'Penicillin Contamination'.
Excerpt: Your firm failed to implement adequate measures to prevent cross-contamination of penicillin products with non-penicillin products.
View Details

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