Drug factory · FDA FEI 3008836669
Clinical Medical Services Inc
240 Sabanetas Ind Pk, Ponce, PR, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 25, 2015.
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 2015: 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 | Clinical Medical Services Inc. | 67191-001, 67191-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 25, 2015 | 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.
Jun 25, 2015 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - 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.
Registered with FDA for: manufacture.