RAPHA Health Network International, Inc
Form 483 issued December 16, 2022 · Doral, Florida
- Inspection
- Nov 30 – Dec 16, 2022
- Investigators
- Dorothy P. Kramer· Jennifer Lalama
- Observations
- 4
- Pages
- 3
- FEI number
- 3013977492
In short: On December 16, 2022, FDA issued a Form 483 with 4 observations to RAPHA Health Network International, Inc in Doral, Florida (FEI 3013977492) after an inspection that ran Nov 30 – Dec 16, 2022. The investigators were Dorothy P. Kramer and Jennifer Lalama. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 02
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 03
Deviations from written production and process…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmRAPHA Health Network International, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RAPHA Health Network International, Inc?
FDA listed 4 observations on this Form 483, mostly about materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected RAPHA Health Network International, Inc?
Dorothy P. Kramer and Jennifer Lalama are named on this Form 483, for the inspection of Nov 30 – Dec 16, 2022. Each investigator has a profile showing what they cite most.
When was RAPHA Health Network International, Inc inspected by FDA?
The inspection ran Nov 30 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
How do I get the full Form 483 for RAPHA Health Network International, 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.