Drug factory · FDA FEI 3004909277
P & J Oxyfill, LLC
1223 Dean Turner Rd, Leakesville, MS, United States
No problems found at FDA's last inspection, Mar 13, 2013.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2010: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | P and J Oxyfill, LLC | 11748-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 13, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 17, 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.
Feb 17, 2010 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units. - 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. - Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labels are used for drug products are not followed. - Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not independently checked, dated, and signed by a second person. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: manufacture.