Aunt Flow Corp
Form 483 issued May 8, 2025 · Columbus, Ohio
- Inspection
- May 5 – May 8, 2025
- Investigator
- Rosanna M. Goodrich
- Observations
- 7
- Pages
- 6
- FEI number
- 3015522042
In short: On May 8, 2025, FDA issued a Form 483 with 7 observations to Aunt Flow Corp in Columbus, Ohio (FEI 3015522042) after an inspection that ran May 5 – May 8, 2025. The investigator was Rosanna M. Goodrich. Most observations concern management controls and cAPA.
At a glance
Management controls and capa account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Requirements that must be met by suppliers, contractors and consultants have…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmAunt Flow Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aunt Flow Corp?
FDA listed 7 observations on this Form 483, mostly about management controls, cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Aunt Flow Corp?
Rosanna M. Goodrich is named on this Form 483, for the inspection of May 5 – May 8, 2025. Each investigator has a profile showing what they cite most.
When was Aunt Flow Corp inspected by FDA?
The inspection ran May 5 – May 8, 2025, and the Form 483 is dated May 8, 2025.
How do I get the full Form 483 for Aunt Flow Corp?
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.