Drug factory · FDA FEI 3007528778
Institutional Care Pharmacy
1815 W County Road 54, Tiffin, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, May 24, 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 | Institutional Care Pharmacy | 44363-1815 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 24, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 14 |
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 24, 2011 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. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not followed that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch. - Written procedures not followed 21 CFR 211.122(a)
Written procedures for the storage and examination of packaging and labeling materials are not followed. - Records not kept for each shipment 21 CFR 211.122(c)
Records are not maintained for each shipment received of each different labeling and packaging material. - Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labeling are used for drug products are not followed. - Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not described in a written procedure. - Accurate reproduction included 21 CFR 211.188(a)
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed. - Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components.
Registered with FDA for: manufacture.