# FDA 483 - Circadia by Dr Pugliese, Inc. - April 01, 2022

Source: https://www.globalkeysolutions.net/records/483/circadia-by-dr-pugliese-inc/0a182c83-e730-488c-acae-57e03bac28e5

> FDA 483 for Circadia by Dr Pugliese, Inc. on April 01, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Circadia by Dr Pugliese, Inc.
- Inspection Date: 2022-04-01
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Circadia by Dr Pugliese, Inc. in Leesport, PA, an OTC drug manufacturer, was cited for multiple significant deficiencies in its quality system. The inspection revealed a lack of validated manufacturing processes, stability testing programs, cleaning validation, supplier CoA verification, finished product testing, and annual product reviews for its drug products, including sunscreen. These issues indicate a severe lack of fundamental controls for ensuring drug product quality and purity.

## Related Officers

- [Michele Gottshall](https://www.globalkeysolutions.net/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.globalkeysolutions.net/companies/circadia-by-dr-pugliese-inc/57c47e31-5ddf-4413-85d3-b8925cbee6de

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8