Drug factory · FDA FEI 2242239
James Alexander Corporation
845 State Route 94, Blairstown, NJ, United States
No problems found at FDA's last inspection, Feb 10, 2025.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2012: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amyl Nitrite | Makes it | James Alexander Corporation | 46414-2222 |
| Hydrogen Peroxide | Makes it, tests it and labels it | Aclaris Therapeutics, Inc. | 71180-001, 71180-002 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 10, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 22, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 10, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 10, 2012 inspection
- Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive identification number and name of equipment to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review 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. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the handling of components.
Registered with FDA for: manufacture.