Llorens Pharmaceuticals International
Form 483 issued August 29, 2019 · Miami, Florida
- Inspection
- Aug 20 – Aug 29, 2019
- Observations
- 1
- Pages
- 2
- FEI number
- 3008468946
In short: On August 29, 2019, FDA issued a Form 483 with 1 observation to Llorens Pharmaceuticals International in Miami, Florida (FEI 3008468946) after an inspection that ran Aug 20 – Aug 29, 2019. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.255 (what is the requirement to establish a batch production record?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.255(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
You did not keep batch production records for…
This inspection in context
Questions about this 483
What did FDA find at Llorens Pharmaceuticals International?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.255 (what is the requirement to establish a batch production record?). The opening words of each observation are shown on this page.
When was Llorens Pharmaceuticals International inspected by FDA?
The inspection ran Aug 20 – Aug 29, 2019, and the Form 483 is dated August 29, 2019.
How do I get the full Form 483 for Llorens Pharmaceuticals International?
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