PIC USA Inc.
Form 483 issued January 30, 2025 · Adolphus, Kentucky
- Inspection
- Jan 28 – Jan 30, 2025
- Investigator
- William F. Lagud
- Observations
- 3
- Pages
- 3
- FEI number
- 3010562164
In short: On January 30, 2025, FDA issued a Form 483 with 3 observations to PIC USA Inc. in Adolphus, Kentucky (FEI 3010562164) after an inspection that ran Jan 28 – Jan 30, 2025. The investigator was William F. Lagud. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Procedures designed to assure that correct labels are used for drug…
This inspection in context
William F. Lagud
3 documents · 2017–2025
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Arizona.
The firmPIC USA Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PIC USA Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected PIC USA Inc.?
William F. Lagud is named on this Form 483, for the inspection of Jan 28 – Jan 30, 2025. Each investigator has a profile showing what they cite most.
When was PIC USA Inc. inspected by FDA?
The inspection ran Jan 28 – Jan 30, 2025, and the Form 483 is dated January 30, 2025.
How do I get the full Form 483 for PIC USA 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.