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FDA establishment 3010002722, Gibbstown, New Jersey, United States. Part of Keystone Industries's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 0
Last inspection ended: Nov 7, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.84(d)(1). Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.72(b). Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, no action was taken to evaluate whether there was any adverse effect on the device's quality.
21 CFR 820.25(a). Personnel Personnel do not have the necessary training to perform their jobs.
Voluntary Action Indicated (VAI)
Dec 21, 2022
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
Voluntary Action Indicated (VAI)
Jun 7, 2018
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.84(e). Rejecting When Specifications Not Met Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
21 CFR 211.110(a). Control procedures to monitor and validate performance 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.
Voluntary Action Indicated (VAI)
Apr 5, 2016
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications are not rejected.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
No Action Indicated (NAI)
Feb 6, 2013
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture, processing, and packing of a drug product lack the education, training, and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include reliable, meaningful, and specific test methods.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
21 CFR 211.186(b)(8). Description of containers, labels, et. al. Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.
21 CFR 211.166(b). Adequate number of batches on stability An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
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
Gibbstown, New Jersey, United States. Part of