Creative Essences Inc
Form 483 issued September 4, 2020 · Santa Fe Springs, California
- Inspection
- Aug 25 – Sep 4, 2020
- Investigator
- Stephanie A. Slater
- Observations
- 11
- Pages
- 16
- FEI number
- 3006349554
In short: On September 4, 2020, FDA issued a Form 483 with 11 observations to Creative Essences Inc in Santa Fe Springs, California (FEI 3006349554) after an inspection that ran Aug 25 – Sep 4, 2020. The investigator was Stephanie A. Slater. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 02
Complaint records are deficient in that they do not include the findings of the…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmCreative Essences Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Creative Essences Inc?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Creative Essences Inc?
Stephanie A. Slater is named on this Form 483, for the inspection of Aug 25 – Sep 4, 2020. Each investigator has a profile showing what they cite most.
When was Creative Essences Inc inspected by FDA?
The inspection ran Aug 25 – Sep 4, 2020, and the Form 483 is dated September 4, 2020.
How do I get the full Form 483 for Creative Essences Inc?
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.