Drug factory · FDA FEI 3002783962
Pacira Pharmaceuticals, Inc.
10450 Science Center Dr, San Diego, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 25, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
12 drug inspections on record since 2009: 1 with no problems, 11 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupivacaine | Makes it and tests it | Pacira Pharmaceuticals, Inc. | 65250-133, 65250-266 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 25, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 23, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jun 17, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 24, 2011 | No problems found | Drug Quality Assurance | — |
| Apr 23, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 10, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 4, 2009 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 19, 2023 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Written calibration / inspection records not kept 21 CFR 211.68(a)
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
Feb 23, 2012 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity. - Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the sampling, testing, approval, and rejection of components.
Jul 10, 2009 inspection
- Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; manufacture.