Orly International, Inc
Form 483 issued December 20, 2022 · Van Nuys, California
- Inspection
- Dec 12 – Dec 20, 2022
- Investigators
- Carolina D. Vasquez· Crystal Monroy
- Observations
- 8
- Pages
- 7
- FEI number
- 3005702355
In short: On December 20, 2022, FDA issued a Form 483 with 8 observations to Orly International, Inc in Van Nuys, California (FEI 3005702355) after an inspection that ran Dec 12 – Dec 20, 2022. The investigators were Carolina D. Vasquez and Crystal Monroy. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 02
There is no written testing program designed to assess the stability…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Yom- firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Carolina D. Vasquez
9 documents · 2022–2026
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in California.
The firmOrly International, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.137(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Orly International, Inc?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Orly International, Inc?
Carolina D. Vasquez and Crystal Monroy are named on this Form 483, for the inspection of Dec 12 – Dec 20, 2022. Each investigator has a profile showing what they cite most.
When was Orly International, Inc inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2022, and the Form 483 is dated December 20, 2022.
How do I get the full Form 483 for Orly International, Inc?
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.