Alaunus Pharmaceutical LLC
Form 483 issued November 16, 2012 · Framingham, Massachusetts
- Inspection
- Oct 19 – Nov 16, 2012
- Investigator
- Debra M. Emerson
- Observations
- 4
- Pages
- 2
- FEI number
- 3008170448
In short: On November 16, 2012, FDA issued a Form 483 with 4 observations to Alaunus Pharmaceutical LLC in Framingham, Massachusetts (FEI 3008170448) after an inspection that ran Oct 19 – Nov 16, 2012. The investigator was Debra M. Emerson. Most observations concern production and materials.
At a glance
Production and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The stability program for the repackaged Fentanyl, Morphine Sulfate, Methadone, Hydromorphone, and Bupivicaine bulk API's…
- 03
The master production records are deficient in that not all critical steps are defined…
- 04
The batch production records…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAlaunus Pharmaceutical LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.94
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alaunus Pharmaceutical LLC?
FDA listed 4 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Alaunus Pharmaceutical LLC?
Debra M. Emerson is named on this Form 483, for the inspection of Oct 19 – Nov 16, 2012. Each investigator has a profile showing what they cite most.
When was Alaunus Pharmaceutical LLC inspected by FDA?
The inspection ran Oct 19 – Nov 16, 2012, and the Form 483 is dated November 16, 2012.
How do I get the full Form 483 for Alaunus Pharmaceutical LLC?
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.