Follet Corporation
Form 483 issued March 29, 2016 · Easton, Pennsylvania
- Inspection
- Mar 18 – Mar 29, 2016
- Investigators
- Alan D. Centi· Brian S. Keefer
- Observations
- 1
- Pages
- 1
- FEI number
- 3005883510
In short: On March 29, 2016, FDA issued a Form 483 with 1 observation to Follet Corporation in Easton, Pennsylvania (FEI 3005883510) after an inspection that ran Mar 18 – Mar 29, 2016. The investigators were Alan D. Centi and Brian S. Keefer. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
1 of 1 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.184 (1×)
What FDA observed
Preview: the opening words of each observation- 01
A device history record has…
This inspection in context
Alan D. Centi
3 documents · 2016–2024
Cites 106.6 (production and in-process control system) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmFollet Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Follet Corporation?
FDA listed 1 observation on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected Follet Corporation?
Alan D. Centi and Brian S. Keefer are named on this Form 483, for the inspection of Mar 18 – Mar 29, 2016. Each investigator has a profile showing what they cite most.
When was Follet Corporation inspected by FDA?
The inspection ran Mar 18 – Mar 29, 2016, and the Form 483 is dated March 29, 2016.
How do I get the full Form 483 for Follet Corporation?
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.