# FDA 483 - Plastikon Healthcare LLC - November 04, 2021

Source: https://www.keypedia.com/records/483/plastikon-healthcare-llc/3b706636-6e64-41b6-bcc7-e70b7df052eb

> FDA 483 for Plastikon Healthcare LLC on November 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Plastikon Healthcare LLC
- Inspection Date: 2021-11-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Plastikon Healthcare LLC in Lawrence, KS, revealed 11 observations concerning significant deficiencies in their drug manufacturing operations. The firm failed to ensure proper component testing, maintain microbial control, thoroughly investigate out-of-specification results, and implement adequate data integrity and quality control procedures. These issues indicate a broad lack of adherence to good manufacturing practices for their over-the-counter drug products.

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/plastikon-healthcare-llc/ee77c99e-ee0b-484d-923a-0cb39739bf8e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8