Exquisite Corporation
Form 483 issued April 26, 2023 · Baldwin Park, California
- Inspection
- Apr 17 – Apr 26, 2023
- Investigator
- Heidy C. Perales
- Observations
- 5
- Pages
- 6
- FEI number
- 1000125142
In short: On April 26, 2023, FDA issued a Form 483 with 5 observations to Exquisite Corporation in Baldwin Park, California (FEI 1000125142) after an inspection that ran Apr 17 – Apr 26, 2023. The investigator was Heidy C. Perales. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility and authority to approve and reject all components, drug product…
- 02
There is no written testing program designed to assess the stability…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Heidy C. Perales
5 documents · 2021–2023
Cites 211.160(b) (general requirements) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Exquisite Corporation?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Exquisite Corporation?
Heidy C. Perales is named on this Form 483, for the inspection of Apr 17 – Apr 26, 2023. Each investigator has a profile showing what they cite most.
When was Exquisite Corporation inspected by FDA?
The inspection ran Apr 17 – Apr 26, 2023, and the Form 483 is dated April 26, 2023.
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.