Westwood Laboratories, LLC
Form 483 issued April 5, 2022 · Azusa, California
- Inspection
- Mar 24 – Apr 5, 2022
- Investigator
- Alan L. Truong
- Observations
- 4
- Pages
- 8
- FEI number
- 2020372
In short: On April 5, 2022, FDA issued a Form 483 with 4 observations to Westwood Laboratories, LLC in Azusa, California (FEI 2020372) after an inspection that ran Mar 24 – Apr 5, 2022. The investigator was Alan L. Truong. Most observations concern production and facilities & equipment.
At a glance
3 of 4 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) 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 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Westwood Laboratories, LLC?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Westwood Laboratories, LLC?
Alan L. Truong is named on this Form 483, for the inspection of Mar 24 – Apr 5, 2022. Each investigator has a profile showing what they cite most.
When was Westwood Laboratories, LLC inspected by FDA?
The inspection ran Mar 24 – Apr 5, 2022, and the Form 483 is dated April 5, 2022.
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.