Zimmer Manufacturing B.V
Form 483 issued November 17, 2015 · Mercedita, Puerto Rico
- Inspection
- Oct 28 – Nov 17, 2015
- Investigators
- Adaliz Santaliz-Cruz· Kimberly Lewandowski-Walker· Laiza V. Garcia
- Observations
- 4
- Pages
- 7
- FEI number
- 1000132037
In short: On November 17, 2015, FDA issued a Form 483 with 4 observations to Zimmer Manufacturing B.V in Mercedita, Puerto Rico (FEI 1000132037) after an inspection that ran Oct 28 – Nov 17, 2015. The investigators were Adaliz Santaliz-Cruz, Kimberly Lewandowski-Walker and Laiza V. Garcia. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 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 have not been adequately established to control product that does not…
- 04
Procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained have…
This inspection in context
Adaliz Santaliz-Cruz
6 documents · 2012–2022
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmZimmer Manufacturing B.V history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zimmer Manufacturing B.V?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Zimmer Manufacturing B.V?
Adaliz Santaliz-Cruz, Kimberly Lewandowski-Walker and Laiza V. Garcia are named on this Form 483, for the inspection of Oct 28 – Nov 17, 2015. Each investigator has a profile showing what they cite most.
When was Zimmer Manufacturing B.V inspected by FDA?
The inspection ran Oct 28 – Nov 17, 2015, and the Form 483 is dated November 17, 2015.
How do I get the full Form 483 for Zimmer Manufacturing B.V?
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.