Creative Essences Inc
Form 483 issued March 25, 2025 · Santa Fe Springs, California
- Inspection
- Mar 19 – Mar 25, 2025
- Investigators
- Aranjeet Singh· Jeffrey P. Raimondi· Thuy T. Nguyen
- Observations
- 11
- Pages
- 11
- FEI number
- 3006349554
In short: On March 25, 2025, FDA issued a Form 483 with 11 observations to Creative Essences Inc in Santa Fe Springs, California (FEI 3006349554) after an inspection that ran Mar 19 – Mar 25, 2025. The investigators were Aranjeet Singh, Jeffrey P. Raimondi and Thuy T. Nguyen. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Aranjeet Singh
3 documents · 2024–2026
Cites 211.192 (production record review) 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 211.192
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, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Creative Essences Inc?
Aranjeet Singh, Jeffrey P. Raimondi and Thuy T. Nguyen are named on this Form 483, for the inspection of Mar 19 – Mar 25, 2025. Each investigator has a profile showing what they cite most.
When was Creative Essences Inc inspected by FDA?
The inspection ran Mar 19 – Mar 25, 2025, and the Form 483 is dated March 25, 2025.
How do I get the full Form 483 for Creative Essences Inc?
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