Drug factory · FDA FEI 1000151288
AHS Investment Corp. dba At Home Medical, Inc.
315 Phillips Ave, South Hackensack, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 27, 2017.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2017: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | At Home Medical, Inc. | 60546-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 27, 2017 | 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.
Feb 27, 2017 inspection
- Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Retest of approved components/containers/closures 21 CFR 211.87
Approved drug product containers are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.
Registered with FDA for: manufacture; relabel; repack.