Ceragroup Industries Inc
Form 483 issued November 25, 2019 · Fort Lauderdale, Florida
- Inspection
- Nov 14 – Nov 25, 2019
- Investigator
- David M. Wilkinson
- Observations
- 5
- Pages
- 6
- FEI number
- 3008501562
In short: On November 25, 2019, FDA issued a Form 483 with 5 observations to Ceragroup Industries Inc in Fort Lauderdale, Florida (FEI 3008501562) after an inspection that ran Nov 14 – Nov 25, 2019. The investigator was David M. Wilkinson. Most observations concern management controls and records & documents.
At a glance
Management controls and records & documents account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Quality audits have not…
- 02
Procedures for device history records have…
- 03
Collective and preventive action activities and/or results have…
- 04
Procedures to ensure equipment is routinely calibrated have…
This inspection in context
David M. Wilkinson
7 documents · 2018–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmCeragroup Industries Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ceragroup Industries Inc?
FDA listed 5 observations on this Form 483, mostly about management controls, records & documents and cAPA. The opening words of each observation are shown on this page.
Who inspected Ceragroup Industries Inc?
David M. Wilkinson is named on this Form 483, for the inspection of Nov 14 – Nov 25, 2019. Each investigator has a profile showing what they cite most.
When was Ceragroup Industries Inc inspected by FDA?
The inspection ran Nov 14 – Nov 25, 2019, and the Form 483 is dated November 25, 2019.
How do I get the full Form 483 for Ceragroup Industries 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.