Drug factory · FDA FEI 1943775
Cee-Kay Supply, Inc.
5835 MANCHESTER AVE, St. Louis, MO, United States
No problems found at FDA's last inspection, May 20, 2014.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2010: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Air | Makes it | Cee-Kay Supply, Inc. | 10218-003 |
| Nitrogen | Makes it | Cee-Kay Supply, Inc. | 10218-102 |
| Oxygen | Makes it | Cee-Kay Supply, Inc. | 10218-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 20, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 19, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 12, 2010 | 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.
May 12, 2010 inspection
- 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 and documented at the time of performance. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
Registered with FDA for: manufacture.