Oregon Compounding Centers, Inc.
Amended 483 issued September 12, 2014 · Wilsonville, Oregon
- Inspection
- Aug 4 – Aug 28, 2014
- Investigators
- Anita Narula· Eileen A. Liu· Heika R. Tait
- Observations
- 10
- Pages
- 11
- FEI number
- 3005580627
In short: On September 12, 2014, FDA issued a Amended 483 with 10 observations to Oregon Compounding Centers, Inc. in Wilsonville, Oregon (FEI 3005580627) after an inspection that ran Aug 4 – Aug 28, 2014. The investigators were Anita Narula, Eileen A. Liu, Heika R. Tait and Jamie M. Du. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and laboratory controls account for 6 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Written records are not made of investigations into the failure of a batch or any of…
- 04
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
6 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmOregon Compounding Centers, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Oregon Compounding Centers, Inc.?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Oregon Compounding Centers, Inc.?
Anita Narula, Eileen A. Liu, Heika R. Tait and Jamie M. Du are named on this Amended 483, for the inspection of Aug 4 – Aug 28, 2014. Each investigator has a profile showing what they cite most.
When was Oregon Compounding Centers, Inc. inspected by FDA?
The inspection ran Aug 4 – Aug 28, 2014, and the Amended 483 is dated September 12, 2014.
How do I get the full Amended 483 for Oregon Compounding Centers, 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.