LTS Lakewood, LLC
Form 483 issued June 6, 2023 · Lakewood, New Jersey
- Inspection
- May 24 – Jun 6, 2023
- Observations
- 4
- Pages
- 5
- FEI number
- 2242829
In short: On June 6, 2023, FDA issued a Form 483 with 4 observations to LTS Lakewood, LLC in Lakewood, New Jersey (FEI 2242829) after an inspection that ran May 24 – Jun 6, 2023. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine inspection and checking of automatic, mechanical, and electronic equipment is not performed according to a…
- 02
Established laboratory control mechanisms are not documented at…
- 03
Deviations from written production and process control…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
This inspection in context
Questions about this 483
What did FDA find at LTS Lakewood, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
When was LTS Lakewood, LLC inspected by FDA?
The inspection ran May 24 – Jun 6, 2023, and the Form 483 is dated June 6, 2023.
How do I get the full Form 483 for LTS Lakewood, 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.