Skyless LLC
Form 483 issued May 16, 2022 · Ponce, Puerto Rico
- Inspection
- May 2 – May 16, 2022
- Investigator
- Ariel Cruz Figueroa
- Observations
- 5
- Pages
- 4
- FEI number
- 3020256087
In short: On May 16, 2022, FDA issued a Form 483 with 5 observations to Skyless LLC in Ponce, Puerto Rico (PR) (FEI 3020256087) after an inspection that ran May 2 – May 16, 2022. The investigator was Ariel Cruz Figueroa. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 5 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
Employees are not given training in the particular operations they perform as part of their function…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSkyless 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Skyless LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Skyless LLC?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of May 2 – May 16, 2022. Each investigator has a profile showing what they cite most.
When was Skyless LLC inspected by FDA?
The inspection ran May 2 – May 16, 2022, and the Form 483 is dated May 16, 2022.
How do I get the full Form 483 for Skyless 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.