Respire Medical Holdings, LLC
Form 483 issued August 15, 2019 · Brooklyn, New York
- Inspection
- Jul 9 – Aug 15, 2019
- Investigators
- Colin E. Tack· Ronald Ifraimov
- Observations
- 1
- Pages
- 10
- FEI number
- 3008937561
In short: On August 15, 2019, FDA issued a Form 483 with 1 observation to Respire Medical Holdings, LLC in Brooklyn, New York (FEI 3008937561) after an inspection that ran Jul 9 – Aug 15, 2019. The investigators were Colin E. Tack and Ronald Ifraimov. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(2) (1×)
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…
This inspection in context
Colin E. Tack
8 documents · 2019–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmRespire Medical Holdings, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Respire Medical Holdings, LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Respire Medical Holdings, LLC?
Colin E. Tack and Ronald Ifraimov are named on this Form 483, for the inspection of Jul 9 – Aug 15, 2019. Each investigator has a profile showing what they cite most.
When was Respire Medical Holdings, LLC inspected by FDA?
The inspection ran Jul 9 – Aug 15, 2019, and the Form 483 is dated August 15, 2019.
How do I get the full Form 483 for Respire Medical Holdings, 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.