Chris, as we discussed yesterday, here are the answers to your questions

Q1. Slnce regulation of compounding pharmacies is mostly leit to the states, what led FDA to inspect Foundation
Care? Was there a complaint, or a tip oranything like that?

A1. Followmg lhe iungal meningitis outbreak in zutz, FDA took steps to identity and inspect high-risk pharmacies that are
known to have engaged in production oi sterile drug products Using a risk--based model, we identified 29 firms lor priority
inspections focused on their sterile processing practices One oi these firms was Foundation Care

02. I see that FDA has posted 3 documents on this page about Foundation Care. Are there any other documents
pertaining to Foundation Care that you can send me?

A2. For additional FDA records, you can submit a Freedom oi lniormation Act (FOIA) request via
Nip accessdata Ida cfin

Q3. I see in a report to the House that FDA inspectors encountered some issues when inspecting Foundation
Care. Here's a quote trom the report, which I've attached (see page 7): "during both our recent proactive and for--
cause pharmacy compounding inspections, several pharmacies delayed or reiused FDA access to records. FDA
encountered refusals oi at least one FDA request during recent inspections oi the toliowing firms and had to
seek administrative warrants in two cases as noted:" 50 my question is what was the refusal at Foundation Care,
and what was the resolution? Did Foundation Care eventually give inspectors the access they needed?

A3. FDA optained sufficient inlormation to complete inspection oi Foundation Care and cannot provide any further
information aboul this matter

Keep me in the loop aboul what you are doing, and to the extent I can get you more info, I am happy to try

Best,

Jeff Ventura M.5., Ms.
Ach 0 Director Strt'leg/