Lingraphicare America, Inc. 103 Carnegie Ctr Ste 104
Form 483 issued November 15, 2019 · Princeton, New Jersey
- Inspection
- Nov 5 – Nov 15, 2019
- Investigators
- Gobiga Vanniyasingam· Michelle L. Johnson
- Observations
- 1
- Pages
- 8
- FEI number
- 1000123978
In short: On November 15, 2019, FDA issued a Form 483 with 1 observation to Lingraphicare America, Inc. 103 Carnegie Ctr Ste 104 in Princeton, New Jersey (FEI 1000123978) after an inspection that ran Nov 5 – Nov 15, 2019. The investigators were Gobiga Vanniyasingam and Michelle L. Johnson. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
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 firmLingraphicare America, Inc. 103 Carnegie Ctr Ste 104 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lingraphicare America, Inc. 103 Carnegie Ctr Ste 104?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Lingraphicare America, Inc. 103 Carnegie Ctr Ste 104?
Gobiga Vanniyasingam and Michelle L. Johnson are named on this Form 483, for the inspection of Nov 5 – Nov 15, 2019. Each investigator has a profile showing what they cite most.
When was Lingraphicare America, Inc. 103 Carnegie Ctr Ste 104 inspected by FDA?
The inspection ran Nov 5 – Nov 15, 2019, and the Form 483 is dated November 15, 2019.
How do I get the full Form 483 for Lingraphicare America, Inc. 103 Carnegie Ctr Ste 104?
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