Diasol East, Inc.
Form 483 issued August 22, 2018 · Watertown, Tennessee
- Inspection
- Aug 7 – Aug 22, 2018
- Investigator
- Mary A. Millner
- Observations
- 12
- Pages
- 18
- FEI number
- 3012248013
In short: On August 22, 2018, FDA issued a Form 483 with 12 observations to Diasol East, Inc. in Watertown, Tennessee (FEI 3012248013) after an inspection that ran Aug 7 – Aug 22, 2018. The investigator was Mary A. Millner. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and capa account for 10 of 12 observations.
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…
- 02
Procedures for finished device acceptance have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
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 12 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. 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 Aug 7 – Aug 22, 2018. Each investigator has a profile showing what they cite most.
When was Diasol East, Inc. inspected by FDA?
The inspection ran Aug 7 – Aug 22, 2018, and the Form 483 is dated August 22, 2018.
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.