Westwood Laboratories, LLC
Form 483 issued November 20, 2023 · Azusa, California
- Inspection
- Oct 30 – Nov 20, 2023
- Investigator
- Carolina D. Vasquez
- Observations
- 7
- Pages
- 7
- FEI number
- 2020372
In short: On November 20, 2023, FDA issued a Form 483 with 7 observations to Westwood Laboratories, LLC in Azusa, California (FEI 2020372) after an inspection that ran Oct 30 – Nov 20, 2023. The investigator was Carolina D. Vasquez. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
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 firmWestwood Laboratories, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Westwood Laboratories, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Westwood Laboratories, LLC?
Carolina D. Vasquez is named on this Form 483, for the inspection of Oct 30 – Nov 20, 2023. Each investigator has a profile showing what they cite most.
When was Westwood Laboratories, LLC inspected by FDA?
The inspection ran Oct 30 – Nov 20, 2023, and the Form 483 is dated November 20, 2023.
How do I get the full Form 483 for Westwood Laboratories, 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.