Oscor, Inc
FDA inspection history in Palm Harbor, Florida, 2016 to 2017
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17One warning letter and one Form 483, at Palm Harbor, Florida.
Cited most
Across all Oscor observations on file
- 21 CFR 820.70Production and process controls2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.30Design controls1
The complete Oscor 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
Palm Harbor, Florida
One Form 483 and one warning letter · 2016 to 2017 · 7 observations
Latest: Form 483, Mar 23, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-03-23 | 483 Form 483 | Palm Harbor, Florida | 7 | $99 |
| 2016-06-13 | Warning letter Warning letter | Palm Harbor, Florida | — | $99 |
Investigators on these documents
Kimberly Lewandowski-Walker (1)Lisa A. Warner (1)Stanley B. Eugene (1)
FEI number 1035166 · most recent document Mar 23, 2017
About Oscor, Inc
How many FDA Form 483s has Oscor, Inc received?
FDA Intel has 1 Form 483 on file for Oscor, Inc; the most recent is dated Mar 23, 2017.
When was Oscor, Inc last inspected by FDA?
The most recent FDA inspection document on file for Oscor, Inc is a Form 483 dated Mar 23, 2017, for the site in Palm Harbor, Florida.
What did FDA cite at Oscor, Inc?
The regulations cited most in the observations on file for Oscor, Inc are 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.184 (Device history record), 1 time.
Has Oscor, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Oscor, Inc; the most recent is dated Jun 13, 2016.