Marlen Manufacturing & Development Co.
FDA inspection history in Bedford, Ohio, 2009 to 2017
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Bedford, Ohio.
- 2017One Form 483, at Bedford, Ohio.
Cited most
Across all Marlen Manufacturing & Development observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Marlen Manufacturing & Development file.
All 2 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
Bedford, Ohio
One Form 483 and one warning letter · 2009 to 2017 · 1 observation
Latest: Form 483, Mar 13, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-13 | 483 Form 483 | Bedford, Ohio | 1 | $99 |
| 2009-08-28 | Warning letter Warning letter | Bedford, Ohio | — | $99 |
Investigators on these documents
FEI number 1520020 · most recent document Mar 13, 2017
About Marlen Manufacturing & Development Co.
How many FDA Form 483s has Marlen Manufacturing & Development Co. received?
FDA Intel has 1 Form 483 on file for Marlen Manufacturing & Development Co.; the most recent is dated Mar 13, 2017.
When was Marlen Manufacturing & Development Co. last inspected by FDA?
The most recent FDA inspection document on file for Marlen Manufacturing & Development Co. is a Form 483 dated Mar 13, 2017, for the site in Bedford, Ohio.
What did FDA cite at Marlen Manufacturing & Development Co.?
The regulations cited most in the observations on file for Marlen Manufacturing & Development Co. are 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Marlen Manufacturing & Development Co. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Marlen Manufacturing & Development Co.; the most recent is dated Aug 28, 2009.