Pharmacy Creations

483 response sent September 3, 2013 · Randolph, New Jersey

Inspection: Aug 5 – Aug 19, 2013
Investigators: Douglas C. Kovacs· Michael R. Klapal
Pages: 4

In short: This is Pharmacy Creations's written response to FDA, dated September 3, 2013, for its site in Randolph, New Jersey. It sets out the corrective actions the firm committed to.

Inside this response

The full response

Every page of the response, exactly as written.

Get the full response

This inspection in context

The investigator

Douglas C. Kovacs

3 documents · 2006–2013

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

The firm

Pharmacy Creations history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Questions about this response

Who inspected Pharmacy Creations?

Douglas C. Kovacs and Michael R. Klapal are named on this 483 response, for the inspection of Aug 5 – Aug 19, 2013. Each investigator has a profile showing what they cite most.

When was Pharmacy Creations inspected by FDA?

The inspection ran Aug 5 – Aug 19, 2013, and the 483 response is dated September 3, 2013.

How do I get the full 483 response for Pharmacy Creations?

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