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FDA establishment 3003428492, White Bear Lake, Minnesota, United States. Part of Epien Medical, Inc.'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: Aug 28, 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 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.25(c). Inadequate number of personnel The number of qualified personnel is inadequate to perform and supervise the manufacture and processing of each drug product.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
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.
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 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 211.84(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 establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
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 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
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 establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Voluntary Action Indicated (VAI)
Jun 15, 2011
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Sep 29, 2009
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not justified.
21 CFR 211.68(a). Written calibration / inspection records not kept Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
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 and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.194(b). Test method modification records do not include Records maintained of any modification of an established method employed in testing do not include the reason for the modification and the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
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
White Bear Lake, Minnesota, United States. Part of