Charles River Laboratories, Inc
Form 483 issued October 17, 2025 · Memphis, Tennessee
- Inspection
- Oct 13 – Oct 17, 2025
- Investigator
- Christine Harman
- Observations
- 1
- Pages
- 3
- FEI number
- 3006500433
In short: On October 17, 2025, FDA issued a Form 483 with 1 observation to Charles River Laboratories, Inc in Memphis, Tennessee (FEI 3006500433) after an inspection that ran Oct 13 – Oct 17, 2025. The investigator was Christine Harman. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for cleaning and maintenance of equipment, in addition to manufacturing training procedures were not updated…
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Charles River Laboratories, Inc?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Charles River Laboratories, Inc?
Christine Harman is named on this Form 483, for the inspection of Oct 13 – Oct 17, 2025. Each investigator has a profile showing what they cite most.
When was Charles River Laboratories, Inc inspected by FDA?
The inspection ran Oct 13 – Oct 17, 2025, and the Form 483 is dated October 17, 2025.
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.