Drug factory · FDA FEI 1218367
GF Health Products, Inc.
33 Plan Way, Bldg. #2, Warwick, RI, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 14, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrate Ion and Silver Cation | Makes it | GF Health Products, Inc., MWI/VetOne | 12165-100, 12165-200, 12165-300 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 14, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Dec 7, 2016 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | 4 |
| Dec 7, 2016 | No problems found | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 14, 2019 inspection
- Label storage access limited to authorized personnel 21 CFR 211.122(d)
Access to the storage area for labels and labeling materials is not limited to authorized personnel. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance. - Identification of Persons Performing Significant Steps 21 CFR 211.188(b)(11)
The batch production and control records are deficient in that they do not include identification of persons performing, supervising and checking each significant step in the operation. - Calculations performed are in the records 21 CFR 211.194(a)(5)
Laboratory records do not include a record of all calculations performed in connection with the test. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Dec 7, 2016 inspection
- Contamination control, Lack of or inadequate procedures 21 CFR 820.70(e)
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been established. - Contamination control, Lack of or inadequate procedures 21 CFR 820.70(e)
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been established. - Nonconforming product control 21 CFR 820.90(a)
Products that do not conform to specifications are not adequately controlled. - Nonconforming product control 21 CFR 820.90(a)
Products that do not conform to specifications are not adequately controlled.
Registered with FDA for: manufacture.