Lannett Company, Inc.
Form 483 issued February 2, 2018 · Seymour, Indiana
- Inspection
- Jan 29 – Feb 2, 2018
- Investigators
- Emilie Kahn· Emily J. Orban
- Observations
- 2
- Pages
- 4
- FEI number
- 1819171
In short: On February 2, 2018, FDA issued a Form 483 with 2 observations to Lannett Company, Inc. in Seymour, Indiana (FEI 1819171) after an inspection that ran Jan 29 – Feb 2, 2018. The investigators were Emilie Kahn and Emily J. Orban. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.188(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lannett Company, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Lannett Company, Inc.?
Emilie Kahn and Emily J. Orban are named on this Form 483, for the inspection of Jan 29 – Feb 2, 2018. Each investigator has a profile showing what they cite most.
When was Lannett Company, Inc. inspected by FDA?
The inspection ran Jan 29 – Feb 2, 2018, and the Form 483 is dated February 2, 2018.
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.