Water-Jel Technologies, LLC
Form 483 issued August 15, 2019 · Huntersville, North Carolina
- Inspection
- Jul 10 – Aug 15, 2019
- Investigators
- Emmanuel J. Ramos· Frank J. Marciniak
- Observations
- 11
- Pages
- 14
- FEI number
- 1219592
In short: On August 15, 2019, FDA issued a Form 483 with 11 observations to Water-Jel Technologies, LLC in Huntersville, North Carolina (FEI 1219592) after an inspection that ran Jul 10 – Aug 15, 2019. The investigators were Emmanuel J. Ramos and Frank J. Marciniak. Most observations concern records & documents and cAPA.
At a glance
Observations span 4 systems, led by records & documents.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
EVPLOFEES) SIGNATURE DarTeissueD Medical Devices Establishment of the reliability of the container supplier's report of analyses…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Medical Devices Procedures for corrective and preventive action have…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmWater-Jel Technologies, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Water-Jel Technologies, LLC?
FDA listed 11 observations on this Form 483, mostly about records & documents, cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Water-Jel Technologies, LLC?
Emmanuel J. Ramos and Frank J. Marciniak are named on this Form 483, for the inspection of Jul 10 – Aug 15, 2019. Each investigator has a profile showing what they cite most.
When was Water-Jel Technologies, LLC inspected by FDA?
The inspection ran Jul 10 – Aug 15, 2019, and the Form 483 is dated August 15, 2019.
How do I get the full Form 483 for Water-Jel Technologies, LLC?
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.