Drug factory · FDA FEI 1030296
Holston Gases, Inc.
368 Terry Blvd, Louisville, KY, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 2, 2011.
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 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Holston Gases, Inc. | 55050-0030 |
| Nitrogen | Makes it | Holston Gases, Inc. | 55050-0016 |
| Nitrous Oxide | Makes it | Holston Gases, Inc. | 55050-0018 |
| Oxygen | Makes it | Holston Gases, Inc. | 55050-0011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 2, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 2, 2011 inspection
- Written procedures not followed 21 CFR 211.122(a)
Written procedures for the receipt and examination of packaging and labeling materials are not followed. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Quarantine - actual practice 21 CFR 211.142(a)
Drug products are not quarantined before being released by the quality control unit. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. - In-process and laboratory control results 21 CFR 211.188(b)(5)
Batch production and control records do not include laboratory control results for each batch of drug product produced. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas necessary to prevent contamination or mix-ups are deficient. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance. - Quarantine of Rejected Components et. al. 21 CFR 211.89
Rejected drug product containers are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Registered with FDA for: manufacture.