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FDA establishment 1211177, Norwalk, Connecticut, United States. Part of K. W. Griffen Co.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 0
Last inspection ended: May 16, 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 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.122(d). Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.22(a). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all drug products.
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 intended use.
Voluntary Action Indicated (VAI)
Mar 15, 2024
Drugs · Bioresearch Monitoring
5 cited references
21 CFR 314.80(j). Failure to maintain records You failed to maintain for a period of 10 years records of all adverse drug experiences known to you, including raw data and any correspondence.
21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
21 CFR 314.80(c)(2)(ii)(A). Incomplete periodic safety report You failed to submit a periodic report containing a narrative summary and analysis of the ADE information for the reporting interval in the report and a history of actions taken since the last report because of adverse drug experiences.
21 CFR 314.80(c)(2). Interval Periodic reports of non-alert adverse drug experiences have not been submitted yearly for an application which was approved three or more years ago.
21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year to the FDA division responsible for reviewing the application.
Voluntary Action Indicated (VAI)
Aug 14, 2018
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
21 CFR 211.84(c)(2). Containers sampled so as to prevent contamination Containers are not opened, sampled and resealed in a manner designed to prevent contamination of their contents, other components and other drug product containers or closures.
21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments is not done at suitable intervals in accordance with an established written program.
21 CFR 211.170(a). Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not retained.
Voluntary Action Indicated (VAI)
Feb 28, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 18, 2010
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
3 cited references
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component.
21 CFR 211.165(c). Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
No Action Indicated (NAI)
Nov 9, 2009
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
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
Norwalk, Connecticut, United States. Part of