Drug factory · FDA FEI 3016965788
Kesin Pharma Corporation
101 Pine Avenue, Oldsmar, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 19, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atovaquone | Repackages it | Kesin Pharma Corporation | 81033-104 |
| Oxcarbazepine | Repackages it | Kesin Pharma Corporation | 81033-113 |
| Potassium Cation | Repackages it | Kesin Pharma Corporation | 81033-412 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 12 |
| Jan 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 12 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 19, 2024 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. - Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: label; pack; repack.