Drug factory · FDA FEI 3001237056
Cmic Cmo USA Corporation
270 Prospect Plains Rd, Cranbury, NJ, United States
No problems found at FDA's last inspection, Mar 31, 2023.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2010: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Olmesartan | Makes it, tests it and packages it | Cosette Pharmaceuticals, Inc. | 0713-0940, 0713-0941, 0713-0942 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 31, 2023 | No problems found | Drug Quality Assurance | — |
| May 4, 2021 | No problems found | Drug Quality Assurance | — |
| Jan 11, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Feb 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 4, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 30, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 8, 2010 | No problems found | 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.
Jan 11, 2018 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. - Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Dec 4, 2013 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Nov 30, 2011 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
Registered with FDA for: analysis; manufacture; pack.