Safeguard US Operating LLC
Form 483 issued March 25, 2022 · Harrisburg, North Carolina
- Inspection
- Mar 21 – Mar 25, 2022
- Investigators
- Adaliz Santaliz-Cruz· Gamal A. Norton
- Observations
- 4
- Pages
- 5
- FEI number
- 3008258694
In short: On March 25, 2022, FDA issued a Form 483 with 4 observations to Safeguard US Operating LLC in Harrisburg, North Carolina (FEI 3008258694) after an inspection that ran Mar 21 – Mar 25, 2022. The investigators were Adaliz Santaliz-Cruz and Gamal A. Norton. Most observations concern cAPA and production & process controls.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 03
Procedures for rework of nonconforming product…
- 04
Labels were not printed so as to remain legible during processing, storage…
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 firmSafeguard US Operating LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Safeguard US Operating LLC?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Safeguard US Operating LLC?
Adaliz Santaliz-Cruz and Gamal A. Norton are named on this Form 483, for the inspection of Mar 21 – Mar 25, 2022. Each investigator has a profile showing what they cite most.
When was Safeguard US Operating LLC inspected by FDA?
The inspection ran Mar 21 – Mar 25, 2022, and the Form 483 is dated March 25, 2022.
How do I get the full Form 483 for Safeguard US Operating 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.