# FDA WARNING_LETTER - Cederroth Industrial Products AB - September 02, 2010

Source: https://www.globalkeysolutions.net/records/warning_letter/cederroth-industrial-products-ab/b02801dc-3d07-46b0-9f73-76b539a00d11

> FDA WARNING_LETTER for Cederroth Industrial Products AB on September 02, 2010. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Cederroth Industrial Products AB
- Inspection Date: 2010-09-02
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 20, 2011, the FDA issued a Warning Letter to Cederroth Industrial Products AB following an inspection from August 30 to September 2, 2010, at their Upplands Vasby, Sweden facility. The inspection revealed that the Cederroth breathing mask and 4-in-1 Bloodstopper are medical devices.

The Cederroth breathing mask was found to be adulterated because the firm lacked an approved premarket approval (PMA) application or an investigational device exemption (IDE). It was also misbranded for failure to submit a 510(k) premarket notification.

All of Cederroth's devices were deemed misbranded because the firm failed to fulfill annual establishment registration and device listing requirements, as mandated by section 510 of the Act.

Additionally, the inspection identified Current Good Manufacturing Practice (CGMP) violations of the Quality System (QS) regulation (21 CFR Part 820):
1.  Failure to establish and maintain adequate procedures for supplier quality requirements (21 CFR 820.50(a)), specifically regarding the validation of a process used by a supplier for the Cederroth 4-in-1 Bloodstopper. The firm's response to this was deemed adequate.
2.  Failure to establish and maintain adequate procedures for incoming product acceptance (21 CFR 820.80(b)),

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/cederroth-industrial-products-ab/ad7770ed-02d6-454c-9012-b072d1b1848b

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7