Lornamead
Form 483 issued April 11, 2023 · Tonawanda, New York
- Inspection
- Feb 27 – Apr 11, 2023
- Investigator
- William Leonard
- Observations
- 5
- Pages
- 5
- FEI number
- 1000120219
In short: On April 11, 2023, FDA issued a Form 483 with 5 observations to Lornamead in Tonawanda, New York (FEI 1000120219) after an inspection that ran Feb 27 – Apr 11, 2023. The investigator was William Leonard. Most observations concern quality system and materials.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
Complaint procedures are deficient in that they do not include provisions that allow for the review…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmLornamead history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lornamead?
FDA listed 5 observations on this Form 483, mostly about quality system, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Lornamead?
William Leonard is named on this Form 483, for the inspection of Feb 27 – Apr 11, 2023. Each investigator has a profile showing what they cite most.
When was Lornamead inspected by FDA?
The inspection ran Feb 27 – Apr 11, 2023, and the Form 483 is dated April 11, 2023.
How do I get the full Form 483 for Lornamead?
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.