John Sjoding AB

Company: John Sjoding AB
Date: 6/29/2004
Product: dental endosseous implants and attachments

Failure to have changes in documents reviewed and approved by an individual in the same function or organization that performed the original review and approval, as required by 21 CFR 820.40(b). For example, on October 16, 2003, the K.A. Rasmussen as. Document Number O-PM-015 Revision 1.01 dated September 18, 2001, used to enter parameters for the [redacted] Machine was changed in the electronic record system from the original written version. The electronic record did not include when the changes became effective or a new revision number and date. According to employees, the October 16, 2003, electronic record was the most up to date record.

FDA District: CDRH

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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Corporate Office

Partners located in the US (CA, FL, MA, MN, TN) and Italy.