PALMETTO ISOTOPES, LLC
Form 483 issued February 28, 2025 · Ridgeland, South Carolina
- Inspection
- Feb 19 – Feb 28, 2025
- Investigator
- Taichun Qin
- Observations
- 6
- Pages
- 6
- FEI number
- 3016492204
In short: On February 28, 2025, FDA issued a Form 483 with 6 observations to PALMETTO ISOTOPES, LLC in Ridgeland, South Carolina (FEI 3016492204) after an inspection that ran Feb 19 – Feb 28, 2025. The investigator was Taichun Qin.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Inadequate routine environmental monitoring in…
- 02FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
- 03FDCA 501(a)(2)(A)
Smoke studies were not…
- 04FDCA 501(a)(2)(A)
Production areas have difficult to clean or contain porous, particle generating, or visibly…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmPALMETTO ISOTOPES, LLC history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at PALMETTO ISOTOPES, LLC?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected PALMETTO ISOTOPES, LLC?
Taichun Qin is named on this Form 483, for the inspection of Feb 19 – Feb 28, 2025. Each investigator has a profile showing what they cite most.
When was PALMETTO ISOTOPES, LLC inspected by FDA?
The inspection ran Feb 19 – Feb 28, 2025, and the Form 483 is dated February 28, 2025.
How do I get the full Form 483 for PALMETTO ISOTOPES, LLC?
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.