# FDA 483 - Particle Size Technology, Inc. - November 13, 2023

Source: https://www.keypedia.com/records/483/particle-size-technology-inc/3d29c791-33d1-46dc-8be2-fcb91efb4633

> FDA 483 for Particle Size Technology, Inc. on November 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Particle Size Technology, Inc.
- Inspection Date: 2023-11-13
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Particle Size Technology, Inc. in Quakertown, PA, a contract API manufacturer, was cited with two significant observations during an FDA inspection. The firm failed to establish adequate written procedures for cleaning API manufacturing equipment, including clean hold times and detailed cleaning steps. Additionally, the inspection revealed insufficient controls over computerized laboratory systems, allowing analysts unauthorized access to alter electronic raw data and lacking audit trail reviews.

## Related Officers

- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/particle-size-technology-inc/d53629c2-2347-400d-bfb3-6e37827cc672

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