Penicillin Contamination

Analytics Overview

Form 483s Issued

483s converted to WL

Total Observation

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 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

15 Sep 2023

ABC Pharmaceuticals Inc.

Drugs

View Form 483

Top Investigators

Investigator Name

Form 483 Count

Warning Letter Count

Jane Smith

John Doe

Justin A Boyd

Jane Doe

John Smith

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
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
Failure to establish and follow adequate written procedures designed to prevent mix-ups and cross-contamination from drug products that contain penicillin ABC Pharmaceuticals Inc.	15 Sep 2023	Normal	Justification: The issue directly pertains to the 'Penicillin Contamination' process type due to insufficient physical separation and control measures between penicillin and non-penicillin manufacturing areas. Excerpt: Inadequate separation was provided to prevent possible contamination and cross-contamination of non-penicillin products. View Details
There is a lack of written procedures for production and process controls ABC Pharmaceuticals	15 Sep 2023	Normal	Justification: Process controls are critical in preventing cross-contamination in facilities handling penicillin, a highly allergenic compound. Excerpt: documented process control for the manufacturing of oral dosage forms of penicillin. View Details

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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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