Westwood Laboratories, LLC
Form 483 issued August 2, 2019 · Azusa, California
- Inspection
- Jul 29 – Aug 2, 2019
- Investigator
- Esteban Beltran
- Observations
- 5
- Pages
- 6
- FEI number
- 2020372
In short: On August 2, 2019, FDA issued a Form 483 with 5 observations to Westwood Laboratories, LLC in Azusa, California (FEI 2020372) after an inspection that ran Jul 29 – Aug 2, 2019. The investigator was Esteban Beltran. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
CAPA and production & process controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures have not been adequately established to control product that does not…
- 03
The device history record does not demonstrate that the device was manufactured in accordance with…
- 04
The equipment used in the manufacturing process does…
This inspection in context
Esteban Beltran
9 documents · 2017–2025
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
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 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Westwood Laboratories, LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Westwood Laboratories, LLC?
Esteban Beltran is named on this Form 483, for the inspection of Jul 29 – Aug 2, 2019. Each investigator has a profile showing what they cite most.
When was Westwood Laboratories, LLC inspected by FDA?
The inspection ran Jul 29 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
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.