Transom Symphony OPCO, LLC
Form 483 issued September 27, 2022 · Rantoul, Illinois
- Inspection
- Sep 19 – Sep 27, 2022
- Investigator
- Peng Zhou
- Observations
- 2
- Pages
- 4
- FEI number
- 1420834
In short: On September 27, 2022, FDA issued a Form 483 with 2 observations to Transom Symphony OPCO, LLC in Rantoul, Illinois (FEI 1420834) after an inspection that ran Sep 19 – Sep 27, 2022. The investigator was Peng Zhou. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmTransom Symphony OPCO, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Transom Symphony OPCO, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Transom Symphony OPCO, LLC?
Peng Zhou is named on this Form 483, for the inspection of Sep 19 – Sep 27, 2022. Each investigator has a profile showing what they cite most.
When was Transom Symphony OPCO, LLC inspected by FDA?
The inspection ran Sep 19 – Sep 27, 2022, and the Form 483 is dated September 27, 2022.
How do I get the full Form 483 for Transom Symphony OPCO, LLC?
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