Medscience Inc
Form 483 issued March 29, 2016 · Delray Beach, Florida
- Inspection
- Mar 1 – Mar 29, 2016
- Investigator
- Karen M. Rodriguez
- Observations
- 11
- Pages
- 6
- FEI number
- 3010131789
In short: On March 29, 2016, FDA issued a Form 483 with 11 observations to Medscience Inc in Delray Beach, Florida (FEI 3010131789) after an inspection that ran Mar 1 – Mar 29, 2016. The investigator was Karen M. Rodriguez. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for acceptance activities…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
This inspection in context
Karen M. Rodriguez
8 documents · 2015–2022
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmMedscience Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medscience Inc?
FDA listed 11 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Medscience Inc?
Karen M. Rodriguez is named on this Form 483, for the inspection of Mar 1 – Mar 29, 2016. Each investigator has a profile showing what they cite most.
When was Medscience Inc inspected by FDA?
The inspection ran Mar 1 – Mar 29, 2016, and the Form 483 is dated March 29, 2016.
How do I get the full Form 483 for Medscience 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.