Autumn Harp, Inc.
Form 483 issued December 19, 2019 · Essex, Vermont
- Inspection
- Dec 16 – Dec 19, 2019
- Investigator
- Edmund F. Mrak
- Observations
- 3
- Pages
- 4
- FEI number
- 3006662277
In short: On December 19, 2019, FDA issued a Form 483 with 3 observations to Autumn Harp, Inc. in Essex, Vermont (FEI 3006662277) after an inspection that ran Dec 16 – Dec 19, 2019. The investigator was Edmund F. Mrak. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Established laboratory control mechanisms…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Written records of major equipment cleaning, maintenance and use are not included…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAutumn Harp, Inc. history
The site's inspection history, in date order.
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 Autumn Harp, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Autumn Harp, Inc.?
Edmund F. Mrak is named on this Form 483, for the inspection of Dec 16 – Dec 19, 2019. Each investigator has a profile showing what they cite most.
When was Autumn Harp, Inc. inspected by FDA?
The inspection ran Dec 16 – Dec 19, 2019, and the Form 483 is dated December 19, 2019.
How do I get the full Form 483 for Autumn Harp, 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.