Lannett Company, Inc.
Form 483 issued October 21, 2022 · Seymour, Indiana
- Inspection
- Oct 21, 2022
- Investigators
- Logan T. Williams· Paranthaman Senthamaraikannan
- Observations
- 3
- Pages
- 3
- FEI number
- 1819171
In short: On October 21, 2022, FDA issued a Form 483 with 3 observations to Lannett Company, Inc. in Seymour, Indiana (FEI 1819171) after an inspection that ran Oct 21, 2022. The investigators were Logan T. Williams and Paranthaman Senthamaraikannan. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Batch production and control records do not include the specific identification of each batch of in…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmLannett Company, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lannett Company, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Lannett Company, Inc.?
Logan T. Williams and Paranthaman Senthamaraikannan are named on this Form 483, for the inspection of Oct 21, 2022. Each investigator has a profile showing what they cite most.
When was Lannett Company, Inc. inspected by FDA?
The inspection ran Oct 21, 2022, and the Form 483 is dated October 21, 2022.
How do I get the full Form 483 for Lannett Company, Inc.?
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.