Mentholatum Company, The
Form 483 issued June 17, 2021 · Orchard Park, New York
- Inspection
- Jun 15 – Jun 17, 2021
- Investigator
- Johnna L. Bleem
- Observations
- 4
- Pages
- 4
- FEI number
- 3000717606
In short: On June 17, 2021, FDA issued a Form 483 with 4 observations to Mentholatum Company, The in Orchard Park, New York (FEI 3000717606) after an inspection that ran Jun 15 – Jun 17, 2021. The investigator was Johnna L. Bleem. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures for sampling and testing plans are not followed…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 03
The plumbing system contains defects that could contribute to the…
- 04FDCA 760(c)(1)
An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS…
This inspection in context
Johnna L. Bleem
6 documents · 2019–2021
Cites 211.67 (equipment cleaning and maintenance) 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 211.165(c)
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 facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Mentholatum Company, The?
Johnna L. Bleem is named on this Form 483, for the inspection of Jun 15 – Jun 17, 2021. Each investigator has a profile showing what they cite most.
When was Mentholatum Company, The inspected by FDA?
The inspection ran Jun 15 – Jun 17, 2021, and the Form 483 is dated June 17, 2021.
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.