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FDA establishment 3005117563, Newtown, Pennsylvania, United States. Part of KVK-Tech's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 12
Official action indicated: 3
Last inspection ended: Mar 14, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 3 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.186(b)(9). Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete manufacturing, control, instructions and specifications.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
21 CFR 211.63. Equipment Design, Size and Location 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.
21 CFR 211.165(e). Test methods The accuracy, sensitivity and reproducibility of test methods have not been.
Official Action Indicated (OAI)
Oct 21, 2024
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Jul 8, 2022
Drugs · Drug Quality Assurance
10 cited references
21 CFR 211.188(b)(10). Documentation of Sampling Performed The batch production and control records are deficient in that they do not include documentation of sampling performed.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.110(d). Rejected in-process materials not quarantined Rejected in-process materials are not identified to prevent their use in manufacturing or processing operations for which they are unsuitable.
21 CFR 211.42(a). Buildings of Suitable Size, Construction, Location 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.
21 CFR 211.68(b). Computer control of master formula records 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.
21 CFR 211.160(b)(4). Instruments, apparatus, et. al. not meeting specs The use of instruments and recording devices not meeting established specifications was observed.
21 CFR 211.67(b). Written procedures not established/followed 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.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Official Action Indicated (OAI)
Apr 16, 2019
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Sep 21, 2018
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Jun 27, 2017
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Dec 11, 2014
Drugs · Drug Quality AssuranceDrugs · Bioresearch Monitoring
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Newtown, Pennsylvania, United States. Part of