Pacira Pharmaceuticals, Inc.
Form 483 issued April 19, 2023 · San Diego, California
- Inspection
- Apr 10 – Apr 19, 2023
- Investigator
- Joey V. Quitania
- Observations
- 2
- Pages
- 6
- FEI number
- 3002783962
In short: On April 19, 2023, FDA issued a Form 483 with 2 observations to Pacira Pharmaceuticals, Inc. in San Diego, California (FEI 3002783962) after an inspection that ran Apr 10 – Apr 19, 2023. The investigator was Joey V. Quitania. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.68(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pacira Pharmaceuticals, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Pacira Pharmaceuticals, Inc.?
Joey V. Quitania is named on this Form 483, for the inspection of Apr 10 – Apr 19, 2023. Each investigator has a profile showing what they cite most.
When was Pacira Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Apr 10 – Apr 19, 2023, and the Form 483 is dated April 19, 2023.
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.