Lifequest Creations LLC
Form 483 issued March 9, 2020 · Marietta, Georgia
- Inspection
- Mar 2 – Mar 9, 2020
- Investigator
- Kara D. Dobbin
- Observations
- 5
- Pages
- 6
- FEI number
- 3014050858
In short: On March 9, 2020, FDA issued a Form 483 with 5 observations to Lifequest Creations LLC in Marietta, Georgia (FEI 3014050858) after an inspection that ran Mar 2 – Mar 9, 2020. The investigator was Kara D. Dobbin. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Written records of major equipment cleaning, maintenance and use are not included…
This inspection in context
Kara D. Dobbin
5 documents · 2017–2020
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in China.
The firmLifequest Creations 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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lifequest Creations LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Lifequest Creations LLC?
Kara D. Dobbin is named on this Form 483, for the inspection of Mar 2 – Mar 9, 2020. Each investigator has a profile showing what they cite most.
When was Lifequest Creations LLC inspected by FDA?
The inspection ran Mar 2 – Mar 9, 2020, and the Form 483 is dated March 9, 2020.
How do I get the full Form 483 for Lifequest Creations 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.