Precision Align LLC

FDA inspection history in Fort Lauderdale, Florida, 2023

1
Form 483

Every document, by year

  • Form 483

2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2023One Form 483, at Fort Lauderdale, Florida.

Cited most

Across all Precision Align observations on file

The complete Precision Align 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
2023-07-20483 Form 483$99

Investigators on these documents

Ebony D. Sanon (1)

FEI number 3021554422 · most recent document Jul 20, 2023

About Precision Align LLC

How many FDA Form 483s has Precision Align LLC received?

FDA Intel has 1 Form 483 on file for Precision Align LLC; the most recent is dated Jul 20, 2023.

When was Precision Align LLC last inspected by FDA?

The most recent FDA inspection document on file for Precision Align LLC is a Form 483 dated Jul 20, 2023, for the site in Fort Lauderdale, Florida.

What did FDA cite at Precision Align LLC?

The regulations cited most in the observations on file for Precision Align LLC are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.25(b) (Personnel), 1 time.