Drug factory · FDA FEI 3008126704
Medical Equipment and Supplies of America, LLC
12035 34th St N Ste One, Saint Petersburg, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 6, 2011.
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 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Medical Equipment and Supplies of America, LLC | 49799-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 6, 2011 | 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 6, 2011 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit. - 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. - Procedures Written and Followed 21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written. - Quarantine - written procedures 21 CFR 211.142(a)
Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed. - 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. - Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to the need for an investigation of any unexplained discrepancy.
Registered with FDA for: manufacture.