Lornamead
Form 483 issued January 21, 2026 · Tonawanda, New York
- Inspection
- Jan 12 – Jan 21, 2026
- Investigator
- Lauren H. Augustyniak
- Observations
- 3
- Pages
- 5
- FEI number
- 1000120219
In short: On January 21, 2026, FDA issued a Form 483 with 3 observations to Lornamead in Tonawanda, New York (FEI 1000120219) after an inspection that ran Jan 12 – Jan 21, 2026. The investigator was Lauren H. Augustyniak. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written test procedures are…
- 02
Written procedures are not established and followed for evaluations done at least annually and including provisions…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Lauren H. Augustyniak
5 documents · 2024–2026
Cites 211.42(c)(10)(iii) (design and construction features) 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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lornamead?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Lornamead?
Lauren H. Augustyniak is named on this Form 483, for the inspection of Jan 12 – Jan 21, 2026. Each investigator has a profile showing what they cite most.
When was Lornamead inspected by FDA?
The inspection ran Jan 12 – Jan 21, 2026, and the Form 483 is dated January 21, 2026.
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.