Zep Inc.
Form 483 issued October 24, 2024 · Emerson, Georgia
- Inspection
- Oct 22 – Oct 24, 2024
- Investigators
- J'maica J. Hunter· Pratik S. Upadhyay
- Observations
- 12
- Pages
- 7
- FEI number
- 3003906462
In short: On October 24, 2024, FDA issued a Form 483 with 12 observations to Zep Inc. in Emerson, Georgia (FEI 3003906462) after an inspection that ran Oct 22 – Oct 24, 2024. The investigators were J'maica J. Hunter and Pratik S. Upadhyay. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
The accuracy, sensitivity and specificity of test methods…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
J'maica J. Hunter
5 documents · 2024–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Georgia.
The firmZep Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zep Inc.?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Zep Inc.?
J'maica J. Hunter and Pratik S. Upadhyay are named on this Form 483, for the inspection of Oct 22 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was Zep Inc. inspected by FDA?
The inspection ran Oct 22 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for Zep 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.