Mentholatum Company, The
Form 483 issued March 23, 2026 · Orchard Park, New York
- Inspection
- Mar 17 – Mar 23, 2026
- Investigator
- Lauren H. Augustyniak
- Observations
- 4
- Pages
- 6
- FEI number
- 3000717606
In short: On March 23, 2026, FDA issued a Form 483 with 4 observations to Mentholatum Company, The in Orchard Park, New York (FEI 3000717606) after an inspection that ran Mar 17 – Mar 23, 2026. The investigator was Lauren H. Augustyniak. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Laboratory records do not include the…
- 03
Determinations of conformance to appropriate written specifications for acceptance are…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
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 firmMentholatum Company, The history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mentholatum Company, The?
FDA listed 4 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 Mentholatum Company, The?
Lauren H. Augustyniak is named on this Form 483, for the inspection of Mar 17 – Mar 23, 2026. Each investigator has a profile showing what they cite most.
When was Mentholatum Company, The inspected by FDA?
The inspection ran Mar 17 – Mar 23, 2026, and the Form 483 is dated March 23, 2026.
How do I get the full Form 483 for Mentholatum Company, The?
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.