Symrise, Inc.
Form 483 issued February 28, 2025 · Goose Creek, South Carolina
- Inspection
- Feb 24 – Feb 28, 2025
- Observations
- 6
- Pages
- 7
- FEI number
- 1049679
In short: On February 28, 2025, FDA issued a Form 483 with 6 observations to Symrise, Inc. in Goose Creek, South Carolina (FEI 1049679) after an inspection that ran Feb 24 – Feb 28, 2025. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit failed to be completely independent and/or perform some core responsibilities: A. Your Quality…
- 02
Your Quality Unit failed to perform Cleaning…
- 03
Your Quality Unit failed to establish appropriate intervals to monitor cleaning procedures to ensure that these…
- 04
Your Quality Unit failed to ensure intermediates that are held for further processing should be stored…
This inspection in context
Questions about this 483
What did FDA find at Symrise, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Symrise, Inc. inspected by FDA?
The inspection ran Feb 24 – Feb 28, 2025, and the Form 483 is dated February 28, 2025.
How do I get the full Form 483 for Symrise, 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.