Westwood Laboratories, LLC
Form 483 issued October 31, 2024 · Azusa, California
- Inspection
- Oct 15 – Oct 31, 2024
- Investigators
- Gloria E. Andia· Stephon D. Tillis
- Observations
- 6
- Pages
- 7
- FEI number
- 2020372
In short: On October 31, 2024, FDA issued a Form 483 with 6 observations to Westwood Laboratories, LLC in Azusa, California (FEI 2020372) after an inspection that ran Oct 15 – Oct 31, 2024. The investigators were Gloria E. Andia and Stephon D. Tillis. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
There is no written testing program designed to assess the stability…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Gloria E. Andia
1 document · 2024
Cites 211.84(d)(1) (testing and approval or rejection of components, drug product containers, and closures) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Westwood Laboratories, LLC?
FDA listed 6 observations on this Form 483, mostly about materials, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Westwood Laboratories, LLC?
Gloria E. Andia and Stephon D. Tillis are named on this Form 483, for the inspection of Oct 15 – Oct 31, 2024. Each investigator has a profile showing what they cite most.
When was Westwood Laboratories, LLC inspected by FDA?
The inspection ran Oct 15 – Oct 31, 2024, and the Form 483 is dated October 31, 2024.
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.