Drug factory · FDA FEI 3001774291
Air Liquide Canada Inc
95 Birmingham St, Hamilton, Canada
Problems found, fixed voluntarily at FDA's last inspection, Mar 13, 2020.
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 2020: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Air Liquide Canada Inc | 74709-002 |
| Oxygen | Makes it | Air Liquide Canada Inc | 74709-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 13, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 11 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 13, 2020 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments and apparatus is not done at suitable intervals in accordance with an established written program. - Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. - Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature. - 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. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions. - Inadequate number of personnel 21 CFR 211.25(c)
The number of qualified personnel is inadequate to perform the manufacture, processing, packing and holding of each drug product. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
Registered with FDA for: manufacture.