Drug factory · FDA FEI 3012971227
Nitto Avecia Pharma Services, Inc.
10 Vanderbilt, Irvine, CA, United States
No problems found at FDA's last inspection, Jul 25, 2025.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alirocumab | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-020, 61755-021 |
| Cemiplimab | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-008 |
| Ketorolac | Tests it | Hospira, Inc. | 0409-3793, 0409-3795, 0409-3796 |
| Verapamil | Tests it | Hospira, Inc. | 0409-1144 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 25, 2025 | No problems found | Drug Quality Assurance | — |
| Jan 24, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 21, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Dec 7, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 2, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 24, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 24, 2020 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Feb 20, 2015 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis.