# FDA 483 - ARCH-Quakertown - March 28, 2019

Source: https://www.keypedia.com/records/483/arch-quakertown/d74eb756-1e35-4948-94a1-2939cf7565c8

> FDA 483 for ARCH-Quakertown on March 28, 2019. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARCH-Quakertown
- Inspection Date: 2019-03-28
- Product Type: devices
- Office Name: Philadelphia District Office
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) from March 27-28, 2019, Wilsey Tool Company Inc., a medical device manufacturer located in Quakertown, PA, received a Form FDA 483 listing three significant observations. These observations highlight areas where the firm's practices indicate potential deviations from established quality system requirements.

The primary issues identified include a lack of validation studies for a critical manufacturing process. Specifically, the company had not validated a specialized process used on implantable devices and orthopedic tools, failing to assess its potential impact on metal fatigue and corrosion resistance. Secondly, essential equipment calibration and maintenance activities for medical device component manufacturing equipment were not adequately documented. Lastly, corrective and preventive action (CAPA) activities lacked sufficient documentation regarding verification of effectiveness. An example cited was CAPA #10033, where documented verification of its effectiveness was absent after engineering drawing specifications were revised.

As an FDA 483, this document serves as notice of inspectional observations and does not represent a final compliance determination. Wilsey Tool Company Inc. is responsible for conducting internal self-audits to identify and correct these and any other violations to meet quality system requirements under the Federal Food, Drug, and Cosmetic Act.

## Related Officers

- [President](https://www.keypedia.com/people/elizabeth-a-rothwell/0b7b1d01-19fe-446c-8402-e06b11f6c19a)
- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/arch-quakertown/fce649b2-8d20-412b-a714-617735657c4e

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