Whitehall/Div of Acorn Engineering Co
FDA inspection history in City of Industry, California, 2017 to 2020
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2017: one warning letter and one amended 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter and one amended 483, at City of Industry, California.
- 2020One close-out letter, at City of Industry, California.
Cited most
Across all Whitehall/Div of Acorn Engineering observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
The complete Whitehall/Div of Acorn Engineering file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
City of Industry, California
One close-out letter, one warning letter and one amended 483 · 2017 to 2020 · 2 observations
Latest: Close-out, Jul 2, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-07-02 | Close-out Close-out letter | City of Industry, California | — | $99 |
| 2017-07-12 | Warning letter Warning letter | City of Industry, California | — | $99 |
| 2017-03-23 | Amended 483 Amended 483 | City of Industry, California | 2 | $99 |
Investigators on these documents
FEI number 1000150265 · most recent document Jul 2, 2020
About Whitehall/Div of Acorn Engineering Co
How many FDA Form 483s has Whitehall/Div of Acorn Engineering Co received?
FDA Intel has 1 Form 483 on file for Whitehall/Div of Acorn Engineering Co; the most recent is dated Mar 23, 2017.
When was Whitehall/Div of Acorn Engineering Co last inspected by FDA?
The most recent FDA inspection document on file for Whitehall/Div of Acorn Engineering Co is a Form 483 dated Mar 23, 2017, for the site in City of Industry, California.
What did FDA cite at Whitehall/Div of Acorn Engineering Co?
The regulations cited most in the observations on file for Whitehall/Div of Acorn Engineering Co are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.
Has Whitehall/Div of Acorn Engineering Co received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Whitehall/Div of Acorn Engineering Co; the most recent is dated Jul 12, 2017.