# FDA 483 - Boothwyn Pharmacy LLC - September 08, 2021

Source: https://www.globalkeysolutions.net/records/483/boothwyn-pharmacy-llc/a6c261eb-5d4a-48ad-9170-e81ee4c42d39

> FDA 483 for Boothwyn Pharmacy LLC on September 08, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boothwyn Pharmacy LLC
- Inspection Date: 2021-09-08
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Boothwyn Pharmacy LLC in Kennett Square, PA, revealed significant deficiencies in the production of both sterile and non-sterile drug products. Observations included inadequate aseptic processing techniques, insufficient cleaning and disinfection procedures, and a lack of proper environmental controls and quality assurance for critical processes like media fills and water quality. These issues indicate a failure to maintain a state of control necessary for drug manufacturing.

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## Related Officers

- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.globalkeysolutions.net/companies/boothwyn-pharmacy-llc/3ac2c2e2-f194-4c53-9125-a7e1bb4a02c4

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