RTP Operating, LLC
Form 483 issued February 16, 2024 · Durham, North Carolina
- Inspection
- Feb 12 – Feb 16, 2024
- Investigators
- Anna Kwilas· Jie He· Laura Demaster
- Observations
- 5
- Pages
- 1
- FEI number
- 3015451326
In short: On February 16, 2024, FDA issued a Form 483 with 5 observations to RTP Operating, LLC in Durham, North Carolina (FEI 3015451326) after an inspection that ran Feb 12 – Feb 16, 2024. The investigators were Anna Kwilas, Jie He, Laura Demaster and Shannila Shrestha. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate procedures to classify events as deviations. Appendix 1 of D-00694, Global Deviation Management, contains a…
- 02
Defined procedures for retesting for Out of…
- 03
Inadequate procedures to trend…
- 04
The disinfectant efficacy study…
This inspection in context
Anna Kwilas
3 documents · 2022–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRTP Operating, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RTP Operating, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected RTP Operating, LLC?
Anna Kwilas, Jie He, Laura Demaster and Shannila Shrestha are named on this Form 483, for the inspection of Feb 12 – Feb 16, 2024. Each investigator has a profile showing what they cite most.
When was RTP Operating, LLC inspected by FDA?
The inspection ran Feb 12 – Feb 16, 2024, and the Form 483 is dated February 16, 2024.
How do I get the full Form 483 for RTP Operating, 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.