Diasol East, Inc.
Form 483 issued March 17, 2017 · Watertown, Tennessee
- Inspection
- Feb 21 – Mar 17, 2017
- Investigator
- Mary A. Millner
- Observations
- 1
- Pages
- 24
- FEI number
- 3012248013
In short: On March 17, 2017, FDA issued a Form 483 with 1 observation to Diasol East, Inc. in Watertown, Tennessee (FEI 3012248013) after an inspection that ran Feb 21 – Mar 17, 2017. The investigator was Mary A. Millner. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
This inspection in context
Mary A. Millner
9 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmDiasol East, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diasol East, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Diasol East, Inc.?
Mary A. Millner is named on this Form 483, for the inspection of Feb 21 – Mar 17, 2017. Each investigator has a profile showing what they cite most.
When was Diasol East, Inc. inspected by FDA?
The inspection ran Feb 21 – Mar 17, 2017, and the Form 483 is dated March 17, 2017.
How do I get the full Form 483 for Diasol East, 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.