EXCITE PHARMA SERVICES, LLC
Form 483 issued October 24, 2023 · LEES SUMMIT, Missouri
- Inspection
- Oct 24, 2023
- Investigator
- Torrey M. Ward
- Observations
- 3
- Pages
- 4
- FEI number
- 3018068257
In short: On October 24, 2023, FDA issued a Form 483 with 3 observations to EXCITE PHARMA SERVICES, LLC in LEES SUMMIT, Missouri (FEI 3018068257) after an inspection that ran Oct 24, 2023. The investigator was Torrey M. Ward. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include the results of any investigation made into any…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Torrey M. Ward
13 documents · 2021–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Iowa.
The firmEXCITE PHARMA SERVICES, 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 EXCITE PHARMA SERVICES, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and laboratory controls. 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 EXCITE PHARMA SERVICES, LLC?
Torrey M. Ward is named on this Form 483, for the inspection of Oct 24, 2023. Each investigator has a profile showing what they cite most.
When was EXCITE PHARMA SERVICES, LLC inspected by FDA?
The inspection ran Oct 24, 2023, and the Form 483 is dated October 24, 2023.
How do I get the full Form 483 for EXCITE PHARMA SERVICES, 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.