Charles River Laboratories, Inc
Form 483 issued October 11, 2024 · Memphis, Tennessee
- Inspection
- Oct 7 – Oct 11, 2024
- Investigators
- Christine Harman· Ou Olivia Ma
- Observations
- 3
- Pages
- 3
- FEI number
- 3006500433
In short: On October 11, 2024, FDA issued a Form 483 with 3 observations to Charles River Laboratories, Inc in Memphis, Tennessee (FEI 3006500433) after an inspection that ran Oct 7 – Oct 11, 2024. The investigators were Christine Harman and Ou Olivia Ma. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
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
The oversight of Quality Assurance (QA) is deficient in ensuring the timely handling of deviations including…
- 02
The environmental controls and manufacturing process are not sufficient to ensure sterility of the…
- 03
Your procedures for testing and qualifying raw materials used in the…
This inspection in context
Christine Harman
4 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Tennessee.
The firmCharles River Laboratories, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Charles River Laboratories, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system, production and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Charles River Laboratories, Inc?
Christine Harman and Ou Olivia Ma are named on this Form 483, for the inspection of Oct 7 – Oct 11, 2024. Each investigator has a profile showing what they cite most.
When was Charles River Laboratories, Inc inspected by FDA?
The inspection ran Oct 7 – Oct 11, 2024, and the Form 483 is dated October 11, 2024.
How do I get the full Form 483 for Charles River Laboratories, Inc?
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.