First Time US Generics LLC

FDA inspection history in Broomall, Pennsylvania, 2018 to 2024

2
Form 483s

Every document, by year

  • Form 483

2018: one Form 483; 2024: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018One Form 483, at Broomall, Pennsylvania.
  2. 2024One Form 483, at Broomall, Pennsylvania.
  3. 2024The longest 483 on file: 1 observation over 3 pages at Broomall, Pennsylvania.

Cited most

Across all First Time US Generics observations on file

The complete First Time US Generics file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2024-01-12483 Form 483$99
2018-02-15483 Form 483$99

Investigators on these documents

Craig D. Zagata (1)

FEI number 3010165871 · most recent document Jan 12, 2024

About First Time US Generics LLC

How many FDA Form 483s has First Time US Generics LLC received?

FDA Intel has 2 Form 483s on file for First Time US Generics LLC; the most recent is dated Jan 12, 2024.

When was First Time US Generics LLC last inspected by FDA?

The most recent FDA inspection document on file for First Time US Generics LLC is a Form 483 dated Jan 12, 2024, for the site in Broomall, Pennsylvania.

What did FDA cite at First Time US Generics LLC?

The regulations cited most in the observations on file for First Time US Generics LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.