TERRIFIC CARE LLC
Form 483 issued February 5, 2019 · Passaic, New Jersey
- Inspection
- Dec 6, 2018 – Feb 5, 2019
- Investigators
- Gobiga Vanniyasingam· William R. Chang
- Observations
- 4
- Pages
- 3
- FEI number
- 3014100519
In short: On February 5, 2019, FDA issued a Form 483 with 4 observations to TERRIFIC CARE LLC in Passaic, New Jersey (FEI 3014100519) after an inspection that ran Dec 6, 2018 – Feb 5, 2019. The investigators were Gobiga Vanniyasingam and William R. Chang. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for control and distribution of finished devices…
- 02
Written MDR procedures have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
Procedures for the control of storage areas and stock rooms…
This inspection in context
Gobiga Vanniyasingam
4 documents · 2018–2019
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in New Jersey.
The firmTERRIFIC CARE LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TERRIFIC CARE LLC?
FDA listed 4 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected TERRIFIC CARE LLC?
Gobiga Vanniyasingam and William R. Chang are named on this Form 483, for the inspection of Dec 6, 2018 – Feb 5, 2019. Each investigator has a profile showing what they cite most.
When was TERRIFIC CARE LLC inspected by FDA?
The inspection ran Dec 6, 2018 – Feb 5, 2019, and the Form 483 is dated February 5, 2019.
How do I get the full Form 483 for TERRIFIC CARE 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.