Llorens Pharmaceuticals International
Form 483 issued March 11, 2020 · Miami, Florida
- Inspection
- Mar 3 – Mar 11, 2020
- Investigator
- Joanne E. King
- Observations
- 4
- Pages
- 4
- FEI number
- 3008468946
In short: On March 11, 2020, FDA issued a Form 483 with 4 observations to Llorens Pharmaceuticals International in Miami, Florida (FEI 3008468946) after an inspection that ran Mar 3 – Mar 11, 2020. The investigator was Joanne E. King. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Adequate lab facilities for testing and approval or rejection of components, in-process materials and drug products…
- 03
The suitability of all testing methods is not verified under actual conditions of use. Electronic records…
- 04
The batch production and control records are deficient in that they do not…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmLlorens Pharmaceuticals International history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Llorens Pharmaceuticals International?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Llorens Pharmaceuticals International?
Joanne E. King is named on this Form 483, for the inspection of Mar 3 – Mar 11, 2020. Each investigator has a profile showing what they cite most.
When was Llorens Pharmaceuticals International inspected by FDA?
The inspection ran Mar 3 – Mar 11, 2020, and the Form 483 is dated March 11, 2020.
How do I get the full Form 483 for Llorens Pharmaceuticals International?
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.