Drug factory · FDA FEI 3005117563
Kvk-Tech, Inc.
110 TERRY DR., Newtown, PA, United States
Serious problems, FDA action at FDA's last inspection, Mar 14, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
13 drug inspections on record since 2009: 3 with no problems, 7 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2025 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Oct 21, 2024 | No problems found | Bioresearch Monitoring | — |
| Jul 8, 2022 | Serious problems, FDA action | Drug Quality Assurance | 10 |
| Apr 16, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| Sep 21, 2018 | No problems found | Bioresearch Monitoring | — |
| Jun 27, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 11, 2014 | No problems found | Bioresearch Monitoring | — |
| Dec 9, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2012 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Aug 1, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 31, 2009 | Problems found, fixed voluntarily | 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.
Mar 14, 2025 inspection
- Test methods 21 CFR 211.165(e)
The accuracy, sensitivity and reproducibility of test methods have not been. - Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete manufacturing, control, instructions and specifications. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 8, 2022 inspection
- Rejected in-process materials not quarantined 21 CFR 211.110(d)
Rejected in-process materials are not identified to prevent their use in manufacturing or processing operations for which they are unsuitable. - Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of instruments and recording devices not meeting established specifications was observed. - Documentation of Sampling Performed 21 CFR 211.188(b)(10)
The batch production and control records are deficient in that they do not include documentation of sampling performed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - 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. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - 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 construction to facilitate cleaning, maintenance, and proper operations. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. - 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. - 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.
Registered with FDA for: analysis; label; manufacture; pack.