LGM Pharma. LLC
Form 483 issued December 4, 2018 · Erlanger, Kentucky
- Inspection
- Sep 17 – Dec 4, 2018
- Investigators
- Jazmine N. Still· Lauren N. Howard
- Observations
- 2
- Pages
- 10
- FEI number
- 3012048333
In short: On December 4, 2018, FDA issued a Form 483 with 2 observations to LGM Pharma. LLC in Erlanger, Kentucky (FEI 3012048333) after an inspection that ran Sep 17 – Dec 4, 2018. The investigators were Jazmine N. Still and Lauren N. Howard. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
Observations span 1 system, led by packaging & labeling.
Most cited: 21 CFR 211.130 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
API products received from an outside supplier were relabeled by removing the manufacturer’s information without…
- 02
API suppliers are not…
This inspection in context
Jazmine N. Still
16 documents · 2017–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmLGM Pharma. LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LGM Pharma. LLC?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected LGM Pharma. LLC?
Jazmine N. Still and Lauren N. Howard are named on this Form 483, for the inspection of Sep 17 – Dec 4, 2018. Each investigator has a profile showing what they cite most.
When was LGM Pharma. LLC inspected by FDA?
The inspection ran Sep 17 – Dec 4, 2018, and the Form 483 is dated December 4, 2018.
How do I get the full Form 483 for LGM Pharma. 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.