Safeguard US Operating LLC

FDA inspection history in Harrisburg, North Carolina, 2022

1
Form 483

Every document, by year

  • Form 483

2022: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2022One Form 483, at Harrisburg, North Carolina.

Cited most

Across all Safeguard US Operating observations on file

The complete Safeguard US Operating file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2022-03-25483 Form 483$99

Investigators on these documents

Adaliz Santaliz-Cruz (1)Gamal A. Norton (1)

FEI number 3008258694 · most recent document Mar 25, 2022

About Safeguard US Operating LLC

How many FDA Form 483s has Safeguard US Operating LLC received?

FDA Intel has 1 Form 483 on file for Safeguard US Operating LLC; the most recent is dated Mar 25, 2022.

When was Safeguard US Operating LLC last inspected by FDA?

The most recent FDA inspection document on file for Safeguard US Operating LLC is a Form 483 dated Mar 25, 2022, for the site in Harrisburg, North Carolina.

What did FDA cite at Safeguard US Operating LLC?

The regulations cited most in the observations on file for Safeguard US Operating LLC are 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.120(a) (Device labeling), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time.

Safeguard US Operating LLC FDA Inspection History & 483s · FDA Intel