RINATI SKIN LLC
Form 483 issued September 22, 2022 · Hawthorne, California
- Inspection
- Sep 19 – Sep 22, 2022
- Investigator
- Khoa Nathan V. Tran
- Observations
- 7
- Pages
- 4
- FEI number
- 3015047898
In short: On September 22, 2022, FDA issued a Form 483 with 7 observations to RINATI SKIN LLC in Hawthorne, California (FEI 3015047898) after an inspection that ran Sep 19 – Sep 22, 2022. The investigator was Khoa Nathan V. Tran. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmRINATI SKIN LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RINATI SKIN LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and materials. 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 RINATI SKIN LLC?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Sep 19 – Sep 22, 2022. Each investigator has a profile showing what they cite most.
When was RINATI SKIN LLC inspected by FDA?
The inspection ran Sep 19 – Sep 22, 2022, and the Form 483 is dated September 22, 2022.
How do I get the full Form 483 for RINATI SKIN LLC?
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