Drug factory · FDA FEI 1721506
American Welding & Gas, Inc.
1346 Monad Rd, Billings, MT, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 24, 2013.
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 2013: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 24, 2013 | 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.
Sep 24, 2013 inspection
- Distribution Recall System 21 CFR 211.150(b)
The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of recording devices is not done at suitable intervals in accordance with an established written program. - Test methods 21 CFR 211.165(e)
The accuracy and sensitivity of test methods have not been established and documented. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning and maintenance are not included in individual equipment logs. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - 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 maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: manufacture.