Exquisite Corporation
Form 483 issued August 1, 2024 · Baldwin Park, California
- Inspection
- Jul 22 – Aug 1, 2024
- Investigator
- Sara H. Gabel
- Observations
- 6
- Pages
- 5
- FEI number
- 1000125142
In short: On August 1, 2024, FDA issued a Form 483 with 6 observations to Exquisite Corporation in Baldwin Park, California (FEI 1000125142) after an inspection that ran Jul 22 – Aug 1, 2024. The investigator was Sara H. Gabel. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability program does not assure testing of the drug product in the same container-closure…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Routine calibration of electronic equipment is not performed according to a written program designed…
- 04
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Sara H. Gabel
6 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmExquisite Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exquisite Corporation?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Exquisite Corporation?
Sara H. Gabel is named on this Form 483, for the inspection of Jul 22 – Aug 1, 2024. Each investigator has a profile showing what they cite most.
When was Exquisite Corporation inspected by FDA?
The inspection ran Jul 22 – Aug 1, 2024, and the Form 483 is dated August 1, 2024.
How do I get the full Form 483 for Exquisite Corporation?
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.