Portage Pharmacy, Inc.
Form 483 issued March 6, 2013 · Portage, Michigan
- Inspection
- Mar 4 – Mar 6, 2013
- Investigators
- Rebecca E. Dombrowski· Russell K. Riley
- Observations
- 14
- Pages
- 7
- FEI number
- 3002652326
In short: On March 6, 2013, FDA issued a Form 483 with 14 observations to Portage Pharmacy, Inc. in Portage, Michigan (FEI 3002652326) after an inspection that ran Mar 4 – Mar 6, 2013. The investigators were Rebecca E. Dombrowski and Russell K. Riley. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 10 of 14 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Batch productioa and control records do not include in-process results for each…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Clothing ofpersonnel engaged in the processing of drug products is not appropriate for…
This inspection in context
Rebecca E. Dombrowski
14 documents · 2006–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmPortage Pharmacy, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Portage Pharmacy, Inc.?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Portage Pharmacy, Inc.?
Rebecca E. Dombrowski and Russell K. Riley are named on this Form 483, for the inspection of Mar 4 – Mar 6, 2013. Each investigator has a profile showing what they cite most.
When was Portage Pharmacy, Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 6, 2013, and the Form 483 is dated March 6, 2013.
How do I get the full Form 483 for Portage Pharmacy, 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.