Keystone Manufacturing LLC
Form 483 issued December 11, 2019 · Kalamazoo, Michigan
- Inspection
- Dec 3 – Dec 11, 2019
- Investigator
- David Gasparovich
- Observations
- 5
- Pages
- 5
- FEI number
- 3008236846
In short: On December 11, 2019, FDA issued a Form 483 with 5 observations to Keystone Manufacturing LLC in Kalamazoo, Michigan (FEI 3008236846) after an inspection that ran Dec 3 – Dec 11, 2019. The investigator was David Gasparovich. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
Management controls and capa account for 4 of 5 observations.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for quality audits have…
- 02
Procedures for collective and preventive action have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
David Gasparovich
8 documents · 2015–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmKeystone Manufacturing LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Keystone Manufacturing LLC?
FDA listed 5 observations on this Form 483, mostly about management controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected Keystone Manufacturing LLC?
David Gasparovich is named on this Form 483, for the inspection of Dec 3 – Dec 11, 2019. Each investigator has a profile showing what they cite most.
When was Keystone Manufacturing LLC inspected by FDA?
The inspection ran Dec 3 – Dec 11, 2019, and the Form 483 is dated December 11, 2019.
How do I get the full Form 483 for Keystone Manufacturing 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.