Rna Pharma, LLC
Form 483 issued March 8, 2024 · Blue Island, Illinois
- Inspection
- Mar 6 – Mar 8, 2024
- Investigator
- Peng Zhou
- Observations
- 4
- Pages
- 4
- FEI number
- 1000114834
In short: On March 8, 2024, FDA issued a Form 483 with 4 observations to Rna Pharma, LLC in Blue Island, Illinois (FEI 1000114834) after an inspection that ran Mar 6 – Mar 8, 2024. The investigator was Peng Zhou. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
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 master…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Buildings used in the manufacture, processing, packing, or holding of a ding product do not have…
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 firmRna Pharma, 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 Rna Pharma, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Rna Pharma, LLC?
Peng Zhou is named on this Form 483, for the inspection of Mar 6 – Mar 8, 2024. Each investigator has a profile showing what they cite most.
When was Rna Pharma, LLC inspected by FDA?
The inspection ran Mar 6 – Mar 8, 2024, and the Form 483 is dated March 8, 2024.
How do I get the full Form 483 for Rna Pharma, 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.