Drug factory · FDA FEI 1019628
J & M Cylinder Gases, Inc.
1702 5th str NW, Decatur, AL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 8, 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 |
|---|---|---|---|
| Nitrogen | Makes it and repackages it | J & M Cylinder Gases, Inc. | 63862-002, 63862-003 |
| Oxygen | Makes it and repackages it | J & M Cylinder Gases, Inc. | 63862-001, 63862-004, 63862-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 8, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 8, 2011 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Destruction of obsolete labeling 21 CFR 211.122(e)
Obsolete or outdated labels, labeling and packaging materials are not destroyed. - Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product. - Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA. - 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 on a continuing basis and 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 identification of components.
Registered with FDA for: repack.