Drug factory · FDA FEI 1216326
Aero All-Gas Company The
3150 Main St, Hartford, CT, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 19, 2017.
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 2010: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Aero All Gas Company | 10014-005 |
| Helium | Makes it | Aero All Gas Company | 10014-004 |
| Nitrogen | Makes it | Aero All Gas Company | 10014-002 |
| Nitrous Oxide | Makes it | Aero All Gas Company | 10014-003 |
| Oxygen | Makes it | Aero All Gas Company | 10014-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 24, 2010 | 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.
Oct 19, 2017 inspection
- 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. - Reporting of adverse drug experience to FDA 21 CFR 211.198(a)
Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration. - 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. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Feb 24, 2010 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit. - Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. - 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. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. - Reporting of adverse drug experience to FDA 21 CFR 211.198(a)
Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.