Prove Labs Inc.
FDA inspection history in Brooklyn, New York, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Brooklyn, New York.
Cited most
Across all Prove Labs observations on file
- 21 CFR 801.50(a)Labeling requirements for stand-alone software1
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
The complete Prove Labs file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Brooklyn, New York
One Form 483 · 2024 · 6 observations
Latest: Form 483, Apr 17, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-17 | 483 Form 483 | Brooklyn, New York | 6 | $99 |
Investigators on these documents
FEI number 3025488663 · most recent document Apr 17, 2024
About Prove Labs Inc.
How many FDA Form 483s has Prove Labs Inc. received?
FDA Intel has 1 Form 483 on file for Prove Labs Inc.; the most recent is dated Apr 17, 2024.
When was Prove Labs Inc. last inspected by FDA?
The most recent FDA inspection document on file for Prove Labs Inc. is a Form 483 dated Apr 17, 2024, for the site in Brooklyn, New York.
What did FDA cite at Prove Labs Inc.?
The regulations cited most in the observations on file for Prove Labs Inc. are 21 CFR 801.50(a) (Labeling requirements for stand-alone software), 1 time; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.