HNC Products Inc.
Form 483 issued March 17, 2020 · Clinton, Illinois
- Inspection
- Mar 10 – Mar 17, 2020
- Investigators
- Constantin Y. Philopoulos· Logan T. Williams
- Observations
- 8
- Pages
- 6
- FEI number
- 3000205427
In short: On March 17, 2020, FDA issued a Form 483 with 8 observations to HNC Products Inc. in Clinton, Illinois (FEI 3000205427) after an inspection that ran Mar 10 – Mar 17, 2020. The investigators were Constantin Y. Philopoulos and Logan T. Williams. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Procedures for the preparation of master production and control records are not described in a…
This inspection in context
Constantin Y. Philopoulos
9 documents · 2010–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmHNC Products 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HNC Products Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected HNC Products Inc.?
Constantin Y. Philopoulos and Logan T. Williams are named on this Form 483, for the inspection of Mar 10 – Mar 17, 2020. Each investigator has a profile showing what they cite most.
When was HNC Products Inc. inspected by FDA?
The inspection ran Mar 10 – Mar 17, 2020, and the Form 483 is dated March 17, 2020.
How do I get the full Form 483 for HNC Products 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.