Fisher Wallace Laboratories LLC
Form 483 issued March 1, 2016 · New York, New York
- Inspection
- Feb 17 – Mar 1, 2016
- Investigators
- Andrew Garufi· Edouard Viard
- Observations
- 5
- Pages
- 4
- FEI number
- 3006258094
In short: On March 1, 2016, FDA issued a Form 483 with 5 observations to Fisher Wallace Laboratories LLC in New York, New York (FEI 3006258094) after an inspection that ran Feb 17 – Mar 1, 2016. The investigators were Andrew Garufi and Edouard Viard. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 5 observations.
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
Corrective and preventive action activities and/or results…
- 03
Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have…
- 04
A device history record…
This inspection in context
Andrew Garufi
11 documents · 2015–2025
Cites 820.80(b) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in New York.
The firmFisher Wallace Laboratories LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fisher Wallace Laboratories LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Fisher Wallace Laboratories LLC?
Andrew Garufi and Edouard Viard are named on this Form 483, for the inspection of Feb 17 – Mar 1, 2016. Each investigator has a profile showing what they cite most.
When was Fisher Wallace Laboratories LLC inspected by FDA?
The inspection ran Feb 17 – Mar 1, 2016, and the Form 483 is dated March 1, 2016.
How do I get the full Form 483 for Fisher Wallace Laboratories 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.