First Time US Generics LLC
Form 483 issued January 12, 2024 · Broomall, Pennsylvania
- Inspection
- Jan 10 – Jan 12, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 3010165871
In short: On January 12, 2024, FDA issued a Form 483 with 1 observation to First Time US Generics LLC in Broomall, Pennsylvania (FEI 3010165871) after an inspection that ran Jan 10 – Jan 12, 2024. 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(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
This inspection in context
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.
When was First Time US Generics LLC inspected by FDA?
The inspection ran Jan 10 – Jan 12, 2024, and the Form 483 is dated January 12, 2024.
How do I get the full Form 483 for First Time US Generics LLC?
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