Drug factory · FDA FEI 1219145
Associates of Cape Cod, Inc.
124 Bernard E. Saint Jean Drive, East Falmouth, MA, United States
No problems found at FDA's last inspection, Jul 16, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cx-055611 | Tests it | Moderna US, Inc. | 80777-114, 80777-115 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 16, 2025 | No problems found | Drug Quality Assurance | — |
| Nov 26, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 11, 2016 | No problems found | Drug Quality Assurance | — |
| May 16, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 9, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2010 | No problems found | 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.
Nov 26, 2019 inspection
- Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - 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.
Registered with FDA for: analysis.