Westwood Laboratories, LLC
Form 483 issued May 30, 2019 · Azusa, California
- Inspection
- May 13 – May 30, 2019
- Observations
- 3
- Pages
- 3
- FEI number
- 2020372
In short: On May 30, 2019, FDA issued a Form 483 with 3 observations to Westwood Laboratories, LLC in Azusa, California (FEI 2020372) after an inspection that ran May 13 – May 30, 2019. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate…
This inspection in context
Questions about this 483
What did FDA find at Westwood Laboratories, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
When was Westwood Laboratories, LLC inspected by FDA?
The inspection ran May 13 – May 30, 2019, and the Form 483 is dated May 30, 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.