First Time US Generics LLC
Form 483 issued February 15, 2018 · Broomall, Pennsylvania
- Inspection
- Feb 9 – Feb 15, 2018
- Investigator
- Craig D. Zagata
- Observations
- 1
- Pages
- 1
- FEI number
- 3010165871
In short: On February 15, 2018, FDA issued a Form 483 with 1 observation to First Time US Generics LLC in Broomall, Pennsylvania (FEI 3010165871) after an inspection that ran Feb 9 – Feb 15, 2018. The investigator was Craig D. Zagata. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Craig D. Zagata
11 documents · 2016–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmFirst Time US Generics 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at First Time US Generics LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected First Time US Generics LLC?
Craig D. Zagata is named on this Form 483, for the inspection of Feb 9 – Feb 15, 2018. Each investigator has a profile showing what they cite most.
When was First Time US Generics LLC inspected by FDA?
The inspection ran Feb 9 – Feb 15, 2018, and the Form 483 is dated February 15, 2018.
How do I get the full Form 483 for First Time US Generics 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.