St. Jude Medical
Amended 483 issued July 6, 2015 · Atlanta, Georgia
- Inspection
- Jun 9 – Jul 6, 2015
- Investigators
- Claudette D. Brooks· Miaja Umaedi
- Observations
- 12
- Pages
- 16
- FEI number
- 3004936110
In short: On July 6, 2015, FDA issued a Amended 483 with 12 observations to St. Jude Medical in Atlanta, Georgia (FEI 3004936110) after an inspection that ran Jun 9 – Jul 6, 2015. The investigators were Claudette D. Brooks and Miaja Umaedi. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 8 of 12 observations.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Corrective and preventive action activities and/or results have…
- 03
Process validation activities have not…
- 04
Production processes were not developed, conducted, controlled, and monitored to ensure that a device…
8 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Claudette D. Brooks
6 documents · 2003–2018
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmSt. Jude Medical history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at St. Jude Medical?
FDA listed 12 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected St. Jude Medical?
Claudette D. Brooks and Miaja Umaedi are named on this Amended 483, for the inspection of Jun 9 – Jul 6, 2015. Each investigator has a profile showing what they cite most.
When was St. Jude Medical inspected by FDA?
The inspection ran Jun 9 – Jul 6, 2015, and the Amended 483 is dated July 6, 2015.
How do I get the full Amended 483 for St. Jude Medical?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.