# FDA 483 - Nice-Pak Products, Inc. - April 20, 2026

Source: https://www.keypedia.com/records/483/nice-pak-products-inc/1f7803e3-356a-43fd-9979-67768ced726e

> FDA 483 for Nice-Pak Products, Inc. on April 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nice-Pak Products, Inc.
- Inspection Date: 2026-04-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Nice-Pak Products, LLC in Mooresville, IN, revealed significant deficiencies in their manufacturing processes for non-sterile OTC drug products. Observations included a lack of cleaning validation for shared equipment, an inadequate environmental monitoring program that omitted critical product-contact surfaces, and poor facility maintenance with damaged and contaminated ceiling tiles directly above production areas. These issues pose a direct risk of contamination to drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)

Company: https://www.keypedia.com/companies/nice-pak-products-inc/675a57a1-c8c6-40db-8b8f-081c66bf4193

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0