Stronghaven, Inc. d.b.a Packaging
Form 483 issued February 21, 2020 · Louisville, Kentucky
- Inspection
- Feb 19 – Feb 21, 2020
- Investigator
- Constantin Y. Philopoulos
- Observations
- 1
- Pages
- 3
- FEI number
- 3004903838
In short: On February 21, 2020, FDA issued a Form 483 with 1 observation to Stronghaven, Inc. d.b.a Packaging in Louisville, Kentucky (FEI 3004903838) after an inspection that ran Feb 19 – Feb 21, 2020. The investigator was Constantin Y. Philopoulos. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete information relating to the production and…
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 firmStronghaven, Inc. d.b.a Packaging history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stronghaven, Inc. d.b.a Packaging?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Stronghaven, Inc. d.b.a Packaging?
Constantin Y. Philopoulos is named on this Form 483, for the inspection of Feb 19 – Feb 21, 2020. Each investigator has a profile showing what they cite most.
When was Stronghaven, Inc. d.b.a Packaging inspected by FDA?
The inspection ran Feb 19 – Feb 21, 2020, and the Form 483 is dated February 21, 2020.
How do I get the full Form 483 for Stronghaven, Inc. d.b.a Packaging?
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.