Symrise, Inc.
Form 483 issued August 27, 2015 · Goose Creek, South Carolina
- Observations
- 2
- Pages
- 2
- FEI number
- 1049679
In short: On August 27, 2015, FDA issued a Form 483 with 2 observations to Symrise, Inc. in Goose Creek, South Carolina (FEI 1049679). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm failed to perform detector calibration for all their GC Systems used…
- 02
Deviation reports have inadequate investigation and…
This inspection in context
Questions about this 483
What did FDA find at Symrise, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Symrise, Inc. inspected by FDA?
This Form 483 is dated August 27, 2015.
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.