Company: John Sjoding AB
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