St. Jude Medical Puerto Rico LLC
FDA inspection history in Arecibo, Maryland, 2012
- 1
- Response
- 1
- Form 483
Every document, by year
- Response
- Form 483
2012: one 483 response and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One 483 response and one Form 483, at Arecibo, Maryland.
Cited most
Across all St. Jude Medical Puerto Rico observations on file
- 21 CFR 820.70Production and process controls2
- 21 CFR 820.130Device packaging1
- 21 CFR 820.140Handling1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.75Process validation1
The complete St. Jude Medical Puerto Rico file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Arecibo, Maryland
One 483 response and one Form 483 · 2012 · 6 observations
Latest: Response, Oct 22, 2012 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-10-22 | Response 483 response | Arecibo, Maryland | — | $199 |
| 2012-10-02 | 483 Form 483 | Arecibo, Maryland | 6 | $99 |
Investigators on these documents
FEI number 3006705815 · most recent document Oct 22, 2012
About St. Jude Medical Puerto Rico LLC
How many FDA Form 483s has St. Jude Medical Puerto Rico LLC received?
FDA Intel has 1 Form 483 on file for St. Jude Medical Puerto Rico LLC; the most recent is dated Oct 2, 2012.
When was St. Jude Medical Puerto Rico LLC last inspected by FDA?
The most recent FDA inspection document on file for St. Jude Medical Puerto Rico LLC is a Form 483 dated Oct 2, 2012, for the site in Arecibo, Maryland.
What did FDA cite at St. Jude Medical Puerto Rico LLC?
The regulations cited most in the observations on file for St. Jude Medical Puerto Rico LLC are 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 820.130 (Device packaging), 1 time; 21 CFR 820.140 (Handling), 1 time.