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Inspection References
Investigations Operations Manual 2004		 Previous Page | Document TOC | Chapter TOC


For 2004, after the initial release of the IOM to the internet and intranet, subsequent changes to these versions of the IOM will be documented in this change log. The changes to the IOM content will be highlighted in yellow. Important changes will be announced via e-mail to ORA users through DFI Field Alerts. The most recent version of the IOM is the official document of record for Field use. Therefore, you must check for updates in the change log that affect your work.

Change Request Submission - refer to IOM Appendix H and complete the form according to the instructions and e-mail to IOM@ORA.FDA.GOV.

Chapter Subchapter / Section / Subsection Brief Description of Change Date of Change
Exhibit 550 Line 24, Registration requirement text changed to " NO " - applies to both domestic and foreign firms for Devices covered by an Investigational Device Exemption (IDE). 07/19/2004
5 530.04 Streamlined reconciliation examination guidance 07/19/2004
4 454.03 Center for Food Safety and Applied Nutrition (CFSAN) section (c)(1)(a) Removed reference to temporary Chantilly, VA mailing address so that samples are shipped to the main address in College Park, MD. Updated names of Office of Cosmetics and Colors Divisions (a) Cosmetics and Compliance; (b) Colors Certification and Technology. Mail symbols remain unchanged. 06/16/2004
5 512 The last sentence in the last paragraph of the Heading "Correction of FDA 483 Errors" was modified to indicate that all deleted 483 observations and/or text will show as " strike-through " text on the 483. 06/15/2004
Exhibit 550 Text change in the matrix at the intersection of Row 2, Column 5 (" COMPLY W/ GMP ") - Changed from " NO " to " YES " Reason: correct error 04/30/2004
7 772.01 1. minor text change made in paragraphs 2 and 3 for consistency: the phrase " initial importers of imported devices " changed to " initial importers of medical devices " 2. text change: foreign " manufacturers " changed to " exporters " in 2nd paragraph due to error. Note: this corresponds with the language in the 2003 IOM 04/30/2004
5 593.03 Individual Narrative Heading Changes: 1. Persons Interviewed and Administrative Data "Persons Interviewed and" removed from Heading 2. Individual Responsibility " and Persons Interviewed " appended to Heading Reason: Persons Interviewed more appropriately belongs in the Individual Responsibility and Persons Interviewed narrative section since the statement " Describe roles and authorities of responsible individuals, including the full names and titles of individuals providing you with information " implicitly states to list the persons you interviewed or provided you with information during your inspection. 04/30/2004

 

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