Parker Laboratories, Inc
Form 483 issued March 20, 2018 · Fairfield, New Jersey
- Inspection
- Jan 30 – Mar 20, 2018
- Investigator
- Li Li
- Observations
- 3
- Pages
- 5
- FEI number
- 2212018
In short: On March 20, 2018, FDA issued a Form 483 with 3 observations to Parker Laboratories, Inc in Fairfield, New Jersey (FEI 2212018) after an inspection that ran Jan 30 – Mar 20, 2018. The investigator was Li Li. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A violation of the FD&C Act involving a device which might present a risk to health…
- 03
Procedures for training and identifying training needs have…
This inspection in context
Li Li
4 documents · 2015–2018
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in New Jersey.
The firmParker Laboratories, 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 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Parker Laboratories, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Parker Laboratories, Inc?
Li Li is named on this Form 483, for the inspection of Jan 30 – Mar 20, 2018. Each investigator has a profile showing what they cite most.
When was Parker Laboratories, Inc inspected by FDA?
The inspection ran Jan 30 – Mar 20, 2018, and the Form 483 is dated March 20, 2018.
How do I get the full Form 483 for Parker Laboratories, 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.