Person and Covey
Form 483 issued February 6, 2025 · Glendale, California
- Inspection
- Jan 27 – Feb 6, 2025
- Investigator
- Gavin T. Cua
- Observations
- 7
- Pages
- 6
- FEI number
- 2011222
In short: On February 6, 2025, FDA issued a Form 483 with 7 observations to Person and Covey in Glendale, California (FEI 2011222) after an inspection that ran Jan 27 – Feb 6, 2025. The investigator was Gavin T. Cua. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
There is no quality…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
All records of production and control associated with a batch of drug product were not maintained…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmPerson and Covey history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Person and Covey?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Person and Covey?
Gavin T. Cua is named on this Form 483, for the inspection of Jan 27 – Feb 6, 2025. Each investigator has a profile showing what they cite most.
When was Person and Covey inspected by FDA?
The inspection ran Jan 27 – Feb 6, 2025, and the Form 483 is dated February 6, 2025.
How do I get the full Form 483 for Person and Covey?
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.