Drug factory · FDA FEI 1122637
Franklin Respiratory and Medical, Inc.
Rocky Mount, Virginia, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Dec 11, 2014.
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 2011: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Franklin Respiratory and Medical, Inc. | 57971-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 6, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Jul 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 11, 2014 inspection
- Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced. - 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.
Mar 6, 2014 inspection
- Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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. - 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. - 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. - Quarantine Storage of Components 21 CFR 211.82(b)
Incoming drug product containers are not stored under quarantine until they have been tested or examined, as appropriate, and released.
Jul 28, 2011 inspection
- 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. - Written calibration / inspection records not kept 21 CFR 211.68(a)
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.