Drug factory · FDA FEI 3002549301
Medcyl Services Ltd
4236 N Orange Blossom Trl, Orlando, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 2012.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2009: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | MedCyl Services, Ltd. | 64673-001, 64673-002, 64673-003 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Dec 28, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 28, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
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 13, 2012 inspection
- Supervisor Training/Education/Experience 21 CFR 211.25(b)
Individuals responsible for supervising the manufacture of a drug product lack the education, training, and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. - Supervisor Training/Education/Experience 21 CFR 211.25(b)
Individuals responsible for supervising the manufacture of a drug product lack the education, training, and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the maintenance, cleaning, sanitizing, and inspection of equipment. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the maintenance, cleaning, sanitizing, and inspection of equipment.
Registered with FDA for: manufacture.