Pacira Pharmaceuticals, Inc.
Form 483 issued July 22, 2015 · San Diego, California
- Inspection
- Jul 6 – Jul 22, 2015
- Investigators
- Paul A. Bonneau· Theresa Kirkham· Virgilio F. Pacio
- Observations
- 7
- Pages
- 5
- FEI number
- 3002783962
In short: On July 22, 2015, FDA issued a Form 483 with 7 observations to Pacira Pharmaceuticals, Inc. in San Diego, California (FEI 3002783962) after an inspection that ran Jul 6 – Jul 22, 2015. The investigators were Paul A. Bonneau, Theresa Kirkham and Virgilio F. Pacio. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There is a lack of written procedures providing cleaning schedules and describing in sufficient detail the…
- 04
Batch production and control records do not include the results of any investigation made into any…
This inspection in context
Paul A. Bonneau
5 documents · 2003–2016
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmPacira Pharmaceuticals, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pacira Pharmaceuticals, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Pacira Pharmaceuticals, Inc.?
Paul A. Bonneau, Theresa Kirkham and Virgilio F. Pacio are named on this Form 483, for the inspection of Jul 6 – Jul 22, 2015. Each investigator has a profile showing what they cite most.
When was Pacira Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jul 6 – Jul 22, 2015, and the Form 483 is dated July 22, 2015.
How do I get the full Form 483 for Pacira Pharmaceuticals, 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.