CoreTex Products Inc.
Form 483 issued April 28, 2021 · Erwin, Tennessee
- Inspection
- Apr 26 – Apr 28, 2021
- Investigator
- Lisa Shin
- Observations
- 3
- Pages
- 4
- FEI number
- 3002719565
In short: On April 28, 2021, FDA issued a Form 483 with 3 observations to CoreTex Products Inc. in Erwin, Tennessee (FEI 3002719565) after an inspection that ran Apr 26 – Apr 28, 2021. The investigator was Lisa Shin. Most observations concern production and packaging & labeling.
At a glance
Production and packaging & labeling account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Strict control is not exercised over labeling issued for use in…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Lisa Shin
13 documents · 2020–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCoreTex Products 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 CoreTex Products Inc.?
FDA listed 3 observations on this Form 483, mostly about production, packaging & labeling and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected CoreTex Products Inc.?
Lisa Shin is named on this Form 483, for the inspection of Apr 26 – Apr 28, 2021. Each investigator has a profile showing what they cite most.
When was CoreTex Products Inc. inspected by FDA?
The inspection ran Apr 26 – Apr 28, 2021, and the Form 483 is dated April 28, 2021.
How do I get the full Form 483 for CoreTex Products 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.