Pentax of America Inc
FDA inspection history in Montvale, New Jersey, 2018
- 1
- Form 483
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2018: one Form 483, one warning letter and one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, one warning letter and one close-out letter, at Montvale, New Jersey.
Cited most
Across all Pentax of America observations on file
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.200(c)Servicing1
The complete Pentax of America file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Montvale, New Jersey
One Form 483, one warning letter and one close-out letter · 2018 · 5 observations
Latest: Form 483, Sep 27, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-09-27 | 483 Form 483 | Montvale, New Jersey | 5 | $99 |
| 2018-03-09 | Warning letter Warning letter | Montvale, New Jersey | — | $99 |
| 2018-01-26 | Close-out Close-out letter | Montvale, New Jersey | — | $99 |
Investigators on these documents
FEI number 1000080301 · most recent document Sep 27, 2018
About Pentax of America Inc
How many FDA Form 483s has Pentax of America Inc received?
FDA Intel has 1 Form 483 on file for Pentax of America Inc; the most recent is dated Sep 27, 2018.
When was Pentax of America Inc last inspected by FDA?
The most recent FDA inspection document on file for Pentax of America Inc is a Form 483 dated Sep 27, 2018, for the site in Montvale, New Jersey.
What did FDA cite at Pentax of America Inc?
The regulations cited most in the observations on file for Pentax of America Inc are 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 803.17(a)(2) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Pentax of America Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pentax of America Inc; the most recent is dated Mar 9, 2018.