# FDA 483 - Karl Storz Endoscopy America Inc - May 24, 2022

Source: https://www.globalkeysolutions.net/records/483/karl-storz-endoscopy-america-inc/a45a3d09-b0ea-460f-aaa5-525d8ea3c08f

> FDA 483 for Karl Storz Endoscopy America Inc on May 24, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Karl Storz Endoscopy America Inc
- Inspection Date: 2022-05-24
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Karl Storz Endoscopy America Inc. in Auburn, MA, revealed significant deficiencies in medical device reporting and corrective and preventive action procedures. The firm failed to submit numerous Medical Device Reports (MDRs) within 30 days for events involving serious injury or death, and its recall process for nonconforming endoscopes was found to be inadequate, lacking proper notification and control over affected products.

## Related Officers

- [Joann F Fujikawa](https://www.globalkeysolutions.net/people/joann-f-fujikawa/c154a8e4-4ae6-4989-b88b-b2f50ebfb983)
- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/karl-storz-endoscopy-america-inc/f4a4bea6-c1cf-4659-9467-fa744b85b08a

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7