Oscor, Inc
Form 483 issued March 23, 2017 · Palm Harbor, Florida
- Inspection
- Mar 6 – Mar 23, 2017
- Investigators
- Kimberly Lewandowski-Walker· Lisa A. Warner· Stanley B. Eugene
- Observations
- 7
- Pages
- 11
- FEI number
- 1035166
In short: On March 23, 2017, FDA issued a Form 483 with 7 observations to Oscor, Inc in Palm Harbor, Florida (FEI 1035166) after an inspection that ran Mar 6 – Mar 23, 2017. The investigators were Kimberly Lewandowski-Walker, Lisa A. Warner and Stanley B. Eugene. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and capa account for 5 of 7 observations.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for changes to a process and procedure have…
- 04
Risk analysis is…
This inspection in context
Kimberly Lewandowski-Walker
5 documents · 2005–2017
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmOscor, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oscor, Inc?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Oscor, Inc?
Kimberly Lewandowski-Walker, Lisa A. Warner and Stanley B. Eugene are named on this Form 483, for the inspection of Mar 6 – Mar 23, 2017. Each investigator has a profile showing what they cite most.
When was Oscor, Inc inspected by FDA?
The inspection ran Mar 6 – Mar 23, 2017, and the Form 483 is dated March 23, 2017.
How do I get the full Form 483 for Oscor, Inc?
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.