Capillus LLC
Form 483 issued May 10, 2016 · Doral, Florida
- Inspection
- Apr 26 – May 10, 2016
- Investigator
- Karen M. Rodriguez
- Observations
- 9
- Pages
- 5
- FEI number
- 3010123655
In short: On May 10, 2016, FDA issued a Form 483 with 9 observations to Capillus LLC in Doral, Florida (FEI 3010123655) after an inspection that ran Apr 26 – May 10, 2016. The investigator was Karen M. Rodriguez. Most observations concern cAPA and production & process controls.
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures have not been adequately established to control product that does not…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
A device history record has…
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 firmCapillus LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Capillus LLC?
FDA listed 9 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 Capillus LLC?
Karen M. Rodriguez is named on this Form 483, for the inspection of Apr 26 – May 10, 2016. Each investigator has a profile showing what they cite most.
When was Capillus LLC inspected by FDA?
The inspection ran Apr 26 – May 10, 2016, and the Form 483 is dated May 10, 2016.
How do I get the full Form 483 for Capillus LLC?
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.