Drug factory · FDA FEI 3003428492

EPIEN Medical, Inc.

4225 White Bear Parkway, Suite 600, St. Paul, MN, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Aug 28, 2025 inspection

• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  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.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Inadequate number of personnel 21 CFR 211.25(c)
  The number of qualified personnel is inadequate to perform and supervise the manufacture and processing of each drug product.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.

Dec 6, 2018 inspection

• Written procedures not established/followed 21 CFR 211.67(b)
  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.
• Component identity verification 21 CFR 211.84(d)(1)
  Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  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.

Dec 11, 2013 inspection

• Written procedures not established/followed 21 CFR 211.67(b)
  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.
• Identity Testing of Each Component 21 CFR 211.84(d)(1)
  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.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  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.

Sep 29, 2009 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not justified.
• Test method modification records do not include 21 CFR 211.194(b)
  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.
• Written calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  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.

Registered with FDA for: manufacture.