Royal Labs Natural Cosmetics, Inc.
Form 483 issued June 30, 2022 · Johns Island, South Carolina
- Investigators
- Harshal J. Desai· Jared P. Stevens
- Observations
- 2
- Pages
- 3
- FEI number
- 3000205861
In short: On June 30, 2022, FDA issued a Form 483 with 2 observations to Royal Labs Natural Cosmetics, Inc. in Johns Island, South Carolina (FEI 3000205861). The investigators were Harshal J. Desai and Jared P. Stevens. Most observations concern materials and packaging & labeling; 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 packaging & labeling account for 2 of 2 observations.
Most cited: 21 CFR 211.84(d)(2) (1×) · 211.122(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
Access to the storage area for labels and labeling materials is not…
This inspection in context
Harshal J. Desai
6 documents · 2022–2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmRoyal Labs Natural Cosmetics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Royal Labs Natural Cosmetics, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and packaging & labeling. 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 Royal Labs Natural Cosmetics, Inc.?
Harshal J. Desai and Jared P. Stevens are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Royal Labs Natural Cosmetics, Inc. inspected by FDA?
This Form 483 is dated June 30, 2022.
How do I get the full Form 483 for Royal Labs Natural Cosmetics, 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.