Drug factory · FDA FEI 1000115400
Alick's Home Medical Equipment, Inc.
17187 State Road 23, South Bend, IN, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 3, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2011: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Alick's Home Medical Equipment, Inc. | 64075-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 3, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Feb 11, 2011 | 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 3, 2021 inspection
- Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Maintenance of Complaint File 21 CFR 211.198(b)
Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints. - 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. - 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. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt and identification of components.
Feb 11, 2011 inspection
- 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. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and 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: manufacture.