Innova Cosmetic Solutions LLC
Form 483 issued November 6, 2019 · Frostproof, Florida
- Inspection
- Nov 5 – Nov 6, 2019
- Investigator
- Saundrea A. Munroe
- Observations
- 4
- Pages
- 4
- FEI number
- 3015134400
In short: On November 6, 2019, FDA issued a Form 483 with 4 observations to Innova Cosmetic Solutions LLC in Frostproof, Florida (FEI 3015134400) after an inspection that ran Nov 5 – Nov 6, 2019. The investigator was Saundrea A. Munroe. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Determinations of conformance to appropriate written specifications for acceptance are…
- 02
The quality control unit lacks authority to review production records to assure that no errors have…
- 03
Each component is not tested for conformity with all appropriate written specifications for…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmInnova Cosmetic Solutions LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innova Cosmetic Solutions LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Innova Cosmetic Solutions LLC?
Saundrea A. Munroe is named on this Form 483, for the inspection of Nov 5 – Nov 6, 2019. Each investigator has a profile showing what they cite most.
When was Innova Cosmetic Solutions LLC inspected by FDA?
The inspection ran Nov 5 – Nov 6, 2019, and the Form 483 is dated November 6, 2019.
How do I get the full Form 483 for Innova 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.