Plastikon Healthcare LLC

24 FDA enforcement actions

24 Total Recalls

6 Class I

18 Class II

0 Class III

Firm Details

Product Types: drug
States: KS

All Recalls

Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I: Dangerous 06/07/2022 drug

Microbial Contamination of Non-Sterile Products.
Class I: Dangerous 06/07/2022 drug

Microbial Contamination of Non-Sterile Products.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I: Dangerous 06/07/2022 drug

Microbial Contamination of Non-Sterile Products
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I: Dangerous 06/07/2022 drug

Microbial Contamination of Non-Sterile Products.
Class II: Risk 06/07/2022 drug

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I: Dangerous 03/24/2022 drug

Microbial Contamination of Non-Sterile Products
Class I: Dangerous 03/24/2022 drug

Microbial Contamination of Non-Sterile Products
Class II: Risk 03/24/2022 drug

CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II: Risk 03/24/2022 drug

CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II: Risk 03/24/2022 drug

CGMP Deviations: Failure to properly investigate failed microbial testing.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.