St. Jude Medical Puerto Rico LLC
Form 483 issued October 2, 2012 · Arecibo, Maryland
- Inspection
- Sep 17 – Oct 2, 2012
- Investigators
- Adaliz Santaliz-Cruz· Noreen Muniz
- Observations
- 6
- Pages
- 5
- FEI number
- 3006705815
In short: On October 2, 2012, FDA issued a Form 483 with 6 observations to St. Jude Medical Puerto Rico LLC in Arecibo, Maryland (FEI 3006705815) after an inspection that ran Sep 17 – Oct 2, 2012. The investigators were Adaliz Santaliz-Cruz and Noreen Muniz. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
5 of 6 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for identifying product during all stages of receipt, production, distribution, and installation have…
- 03
Process validation activities and results have not been…
- 04
Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration…
This inspection in context
Adaliz Santaliz-Cruz
6 documents · 2012–2022
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSt. Jude Medical Puerto Rico LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at St. Jude Medical Puerto Rico LLC?
FDA listed 6 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected St. Jude Medical Puerto Rico LLC?
Adaliz Santaliz-Cruz and Noreen Muniz are named on this Form 483, for the inspection of Sep 17 – Oct 2, 2012. Each investigator has a profile showing what they cite most.
When was St. Jude Medical Puerto Rico LLC inspected by FDA?
The inspection ran Sep 17 – Oct 2, 2012, and the Form 483 is dated October 2, 2012.
How do I get the full Form 483 for St. Jude Medical Puerto Rico LLC?
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.