Whitehall/Div of Acorn Engineering Co
Amended 483 issued March 23, 2017 · City of Industry, California
- Inspection
- Mar 6 – Mar 23, 2017
- Investigator
- Donna L. Besone
- Observations
- 2
- Pages
- 6
- FEI number
- 1000150265
In short: On March 23, 2017, FDA issued a Amended 483 with 2 observations to Whitehall/Div of Acorn Engineering Co in City of Industry, California (FEI 1000150265) after an inspection that ran Mar 6 – Mar 23, 2017. The investigator was Donna L. Besone. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 2 observations on this amended 483 concern capa.
Most cited: 21 CFR 803.17 (1×) · 803.50(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Donna L. Besone
1 document · 2017
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in California.
The firmWhitehall/Div of Acorn Engineering Co history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Whitehall/Div of Acorn Engineering Co?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Whitehall/Div of Acorn Engineering Co?
Donna L. Besone is named on this Amended 483, for the inspection of Mar 6 – Mar 23, 2017. Each investigator has a profile showing what they cite most.
When was Whitehall/Div of Acorn Engineering Co inspected by FDA?
The inspection ran Mar 6 – Mar 23, 2017, and the Amended 483 is dated March 23, 2017.
How do I get the full Amended 483 for Whitehall/Div of Acorn Engineering Co?
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.