Colgate-Palmolive Company
Form 483 issued July 15, 2021 · Morristown, Tennessee
- Inspection
- Jul 12 – Jul 15, 2021
- Investigators
- Benjamin E. Bowen· Gamal A. Norton
- Observations
- 4
- Pages
- 5
- FEI number
- 3005874880
In short: On July 15, 2021, FDA issued a Form 483 with 4 observations to Colgate-Palmolive Company in Morristown, Tennessee (FEI 3005874880) after an inspection that ran Jul 12 – Jul 15, 2021. The investigators were Benjamin E. Bowen and Gamal A. Norton. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
MDR event files do not contain or reference all adverse event information in the possession of…
- 02
Procedures for monitoring and control of process parameters for a validated process have…
- 03
Complaints involving the possible failure of a device and packaging to meet any of its specifications…
- 04
Procedures to ensure equipment is routinely calibrated have…
This inspection in context
Benjamin E. Bowen
4 documents · 2021–2025
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Tennessee.
The firmColgate-Palmolive Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.18(b)(1)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Colgate-Palmolive Company?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Colgate-Palmolive Company?
Benjamin E. Bowen and Gamal A. Norton are named on this Form 483, for the inspection of Jul 12 – Jul 15, 2021. Each investigator has a profile showing what they cite most.
When was Colgate-Palmolive Company inspected by FDA?
The inspection ran Jul 12 – Jul 15, 2021, and the Form 483 is dated July 15, 2021.
How do I get the full Form 483 for Colgate-Palmolive Company?
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.