Packaging Group Corp
Form 483 issued June 6, 2017 · Michigan City, Indiana
- Inspection
- May 23 – Jun 6, 2017
- Investigator
- Constantin Y. Philopoulos
- Observations
- 2
- Pages
- 6
- FEI number
- 3010838254
In short: On June 6, 2017, FDA issued a Form 483 with 2 observations to Packaging Group Corp in Michigan City, Indiana (FEI 3010838254) after an inspection that ran May 23 – Jun 6, 2017. The investigator was Constantin Y. Philopoulos. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×) · 211.188(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The batch production and control records are deficient in that they do not include documentation of…
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 firmPackaging Group Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Packaging Group Corp?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Packaging Group Corp?
Constantin Y. Philopoulos is named on this Form 483, for the inspection of May 23 – Jun 6, 2017. Each investigator has a profile showing what they cite most.
When was Packaging Group Corp inspected by FDA?
The inspection ran May 23 – Jun 6, 2017, and the Form 483 is dated June 6, 2017.
How do I get the full Form 483 for Packaging Group Corp?
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.