Pharma Pac, LLC
Form 483 issued June 18, 2019 · De Kalb, Mississippi
- Inspection
- Jun 18, 2019
- Investigator
- Nicholas Z. Lu
- Observations
- 3
- Pages
- 3
- FEI number
- 3003982004
In short: On June 18, 2019, FDA issued a Form 483 with 3 observations to Pharma Pac, LLC in De Kalb, Mississippi (FEI 3003982004) after an inspection that ran Jun 18, 2019. The investigator was Nicholas Z. Lu. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Nicholas Z. Lu
10 documents · 2018–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmPharma Pac, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharma Pac, LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Pharma Pac, LLC?
Nicholas Z. Lu is named on this Form 483, for the inspection of Jun 18, 2019. Each investigator has a profile showing what they cite most.
When was Pharma Pac, LLC inspected by FDA?
The inspection ran Jun 18, 2019, and the Form 483 is dated June 18, 2019.
How do I get the full Form 483 for Pharma Pac, LLC?
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.