Keystone Industries
Form 483 issued July 25, 2025 · Cherry Hill, New Jersey
- Inspection
- Jul 21 – Jul 25, 2025
- Investigator
- Esteban Beltran
- Observations
- 7
- Pages
- 38
- FEI number
- 1000121639
In short: On July 25, 2025, FDA issued a Form 483 with 7 observations to Keystone Industries in Cherry Hill, New Jersey (FEI 1000121639) after an inspection that ran Jul 21 – Jul 25, 2025. The investigator was Esteban Beltran. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 6 of 7 observations.
Most cited: 21 CFR 820.198(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Production processes were not conducted and controlled to ensure that a device…
- 03
Procedures for corrective and preventive action have…
- 04
Complaint files are not…
This inspection in context
Esteban Beltran
9 documents · 2017–2025
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmKeystone Industries history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Keystone Industries?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Keystone Industries?
Esteban Beltran is named on this Form 483, for the inspection of Jul 21 – Jul 25, 2025. Each investigator has a profile showing what they cite most.
When was Keystone Industries inspected by FDA?
The inspection ran Jul 21 – Jul 25, 2025, and the Form 483 is dated July 25, 2025.
How do I get the full Form 483 for Keystone Industries?
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.