LTS Lakewood, LLC
Form 483 issued August 22, 2019 · Lakewood, New Jersey
- Inspection
- Aug 15 – Aug 22, 2019
- Investigator
- Russell J. Glapion
- Observations
- 2
- Pages
- 2
- FEI number
- 2242829
In short: On August 22, 2019, FDA issued a Form 483 with 2 observations to LTS Lakewood, LLC in Lakewood, New Jersey (FEI 2242829) after an inspection that ran Aug 15 – Aug 22, 2019. The investigator was Russell J. Glapion. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.103 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Actual yield and percentages of theoretical yield are not determined at the conclusioin of each appropriate…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmLTS Lakewood, LLC history
All 2 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 LTS Lakewood, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected LTS Lakewood, LLC?
Russell J. Glapion is named on this Form 483, for the inspection of Aug 15 – Aug 22, 2019. Each investigator has a profile showing what they cite most.
When was LTS Lakewood, LLC inspected by FDA?
The inspection ran Aug 15 – Aug 22, 2019, and the Form 483 is dated August 22, 2019.
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.