Pacira Pharmaceuticals, Inc.
Form 483 issued March 1, 2018 · San Diego, California
- Inspection
- Feb 21 – Mar 1, 2018
- Observations
- 6
- Pages
- 5
- FEI number
- 3002783962
In short: On March 1, 2018, FDA issued a Form 483 with 6 observations to Pacira Pharmaceuticals, Inc. in San Diego, California (FEI 3002783962) after an inspection that ran Feb 21 – Mar 1, 2018. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Establishment of the reliability of the closure supplier's report of analyses is deficient in that the…
This inspection in context
Questions about this 483
What did FDA find at Pacira Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
When was Pacira Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 21 – Mar 1, 2018, and the Form 483 is dated March 1, 2018.
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.