Kelada Creative Group, LLC
Form 483 issued February 1, 2019 · Richmond, Texas
- Inspection
- Oct 15, 2018 – Feb 1, 2019
- Investigator
- Shatina R. Alridge
- Observations
- 4
- Pages
- 3
- FEI number
- 3013388272
In short: On February 1, 2019, FDA issued a Form 483 with 4 observations to Kelada Creative Group, LLC in Richmond, Texas (FEI 3013388272) after an inspection that ran Oct 15, 2018 – Feb 1, 2019. The investigator was Shatina R. Alridge. Most observations concern packaging & labeling and production.
At a glance
Packaging & labeling and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
In-process materials are not tested for identity, strength, quality and purity and approved or rejected by…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 04
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and…
This inspection in context
Shatina R. Alridge
10 documents · 2015–2020
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
The firmKelada Creative Group, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kelada Creative Group, LLC?
FDA listed 4 observations on this Form 483, mostly about packaging & labeling, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Kelada Creative Group, LLC?
Shatina R. Alridge is named on this Form 483, for the inspection of Oct 15, 2018 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was Kelada Creative Group, LLC inspected by FDA?
The inspection ran Oct 15, 2018 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
How do I get the full Form 483 for Kelada Creative Group, 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.