Drug factory · FDA FEI 3002253355
Velacorp dba Lee's Pharmacy & Medical Equipment
1901 South 1st St. Ste. 100, McAllen, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 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 | Velacorp, Inc. dba Lee's Pharmacy & Medical Equipment | 64504-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
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 27, 2011 inspection
- Examination of packaging and labeling 21 CFR 211.130(d)
Examination of packaging and labeling materials for suitability and correctness before packaging operations is not performed. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance. - Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
Master production and control records lack a specimen or copy of each label and all other labeling. - In-process and laboratory control results 21 CFR 211.188(b)(5)
Batch production and control records do not include in-process results for each batch of drug product produced. - Representative Samples 21 CFR 211.84(b)
Representative samples are not taken of each shipment of each lot of components for testing or examination.
Registered with FDA for: manufacture.