Phillips Precision, Inc
Form 483 issued July 17, 2024 · Elmwood Park, New Jersey
- Inspection
- Apr 22 – Jul 17, 2024
- Investigators
- Jonathan Ho· Naakesh N. Gomanie
- Observations
- 8
- Pages
- 27
- FEI number
- 3003387384
In short: On July 17, 2024, FDA issued a Form 483 with 8 observations to Phillips Precision, Inc in Elmwood Park, New Jersey (FEI 3003387384) after an inspection that ran Apr 22 – Jul 17, 2024. The investigators were Jonathan Ho and Naakesh N. Gomanie. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
5 of 8 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for monitoring and control of process parameters for a validated process have…
- 03
Procedmes for collective and preventive action have…
- 04
Procediues have not been adequately established to control product that does not…
This inspection in context
Jonathan Ho
1 document · 2024
Cites 820.70(e) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmPhillips Precision, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Phillips Precision, Inc?
FDA listed 8 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Phillips Precision, Inc?
Jonathan Ho and Naakesh N. Gomanie are named on this Form 483, for the inspection of Apr 22 – Jul 17, 2024. Each investigator has a profile showing what they cite most.
When was Phillips Precision, Inc inspected by FDA?
The inspection ran Apr 22 – Jul 17, 2024, and the Form 483 is dated July 17, 2024.
How do I get the full Form 483 for Phillips Precision, Inc?
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.