Cosmetic Solutions, LLC
Form 483 issued September 22, 2023 · Boca Raton, Florida
- Inspection
- Sep 15 – Sep 22, 2023
- Investigators
- Bryce Cargo· Conner N. Mann
- Observations
- 4
- Pages
- 6
- FEI number
- 3002692859
In short: On September 22, 2023, FDA issued a Form 483 with 4 observations to Cosmetic Solutions, LLC in Boca Raton, Florida (FEI 3002692859) after an inspection that ran Sep 15 – Sep 22, 2023. The investigators were Bryce Cargo and Conner N. Mann. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of…
- 02
You failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans…
- 03
B. The current SOP P-RD-001 Rev 6, Stability Testing and Expiratory Dating Determination, dated 08/31/2023, does…
- 04
Your quality control unit failed to exercise its responsibility to ensure drug products manufactured are in…
This inspection in context
Bryce Cargo
1 document · 2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmCosmetic Solutions, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmetic Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Cosmetic Solutions, LLC?
Bryce Cargo and Conner N. Mann are named on this Form 483, for the inspection of Sep 15 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Cosmetic Solutions, LLC inspected by FDA?
The inspection ran Sep 15 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Cosmetic Solutions, 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.