Formulated Solutions Cleveland, LLC
Form 483 issued April 12, 2024 · Cleveland, Tennessee
- Inspection
- Apr 8 – Apr 12, 2024
- Investigator
- Gretchen M. Laws
- Observations
- 1
- Pages
- 2
- FEI number
- 3015881013
In short: On April 12, 2024, FDA issued a Form 483 with 1 observation to Formulated Solutions Cleveland, LLC in Cleveland, Tennessee (FEI 3015881013) after an inspection that ran Apr 8 – Apr 12, 2024. The investigator was Gretchen M. Laws. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Gretchen M. Laws
2 documents · 2022–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
The firmFormulated Solutions Cleveland, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Formulated Solutions Cleveland, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Formulated Solutions Cleveland, LLC?
Gretchen M. Laws is named on this Form 483, for the inspection of Apr 8 – Apr 12, 2024. Each investigator has a profile showing what they cite most.
When was Formulated Solutions Cleveland, LLC inspected by FDA?
The inspection ran Apr 8 – Apr 12, 2024, and the Form 483 is dated April 12, 2024.
How do I get the full Form 483 for Formulated Solutions Cleveland, 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.