Drug factory · FDA FEI 3009686761
Chartwell Pharmaceuticals Carmel, LLC.
1033 Stoneleigh Ave, Carmel, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 6, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
11 drug inspections on record since 2009: 4 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 6, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Dec 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 28, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 2, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 23, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Dec 23, 2013 | No problems found | Bioresearch Monitoring | 8 |
| Apr 25, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 21, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 22, 2009 | No problems found | Drug Quality Assurance | — |
| Apr 22, 2009 | No problems found | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 6, 2022 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit. - Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of of the drug product. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Mfg / Processing Operations Area 21 CFR 211.42(c)(5)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing 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. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Feb 28, 2018 inspection
- Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of equipment is not performed according to a written program designed to assure proper performance.
Dec 23, 2013 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed 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 and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Mar 25, 2013 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and written.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.