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FDA establishment 1281412, Shelton, Connecticut, United States. Part of Centrix's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Mar 2, 2022
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(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 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.82(a). Examination on receipt, before acceptance Each container or grouping of containers of components is not examined visually upon receipt and before acceptance for appropriate labeling as to contents.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices.
Voluntary Action Indicated (VAI)
Jan 31, 2017
Drugs · Unapproved and Misbranded DrugsDrugs · Drug Quality Assurance
8 cited references
21 CFR 211.186(b)(7). Theoretical yield statement including percentages Master production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
21 CFR 211.67(b). Written procedures not established/followed 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.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.82(a). Examination on receipt, before acceptance Each container or grouping of containers of components is not examined visually upon receipt and before acceptance for appropriate labeling as to contents.
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Shelton, Connecticut, United States. Part of