Pencol Compounding Pharmacy

483 response sent September 12, 2016 · Denver, Colorado

Inspection: Aug 8 – Aug 22, 2016
Investigators: Michael E. Maselli· Zachary A. Bogorad· Zachary L. Miller
Pages: 8

In short: This is Pencol Compounding Pharmacy's written response to FDA, dated September 12, 2016, for its site in Denver, Colorado. It sets out the corrective actions the firm committed to.

Inside this response

The full response

Every page of the response, exactly as written.

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This inspection in context

The investigator

Michael E. Maselli

6 documents · 2015–2023

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Colorado.

The firm

Pencol Compounding Pharmacy history

The site's inspection history, in date order.

Questions about this response

Who inspected Pencol Compounding Pharmacy?

Michael E. Maselli, Zachary A. Bogorad and Zachary L. Miller are named on this 483 response, for the inspection of Aug 8 – Aug 22, 2016. Each investigator has a profile showing what they cite most.

When was Pencol Compounding Pharmacy inspected by FDA?

The inspection ran Aug 8 – Aug 22, 2016, and the 483 response is dated September 12, 2016.

How do I get the full 483 response for Pencol Compounding Pharmacy?

Download the original PDF from FDA Intel for $199, with no subscription. You also get an invoice PDF with the order.