Drug factory · FDA FEI 1036365

Hill Dermaceuticals, Inc.

2650 SOUTH MELLONVILLE AVENUE, Sanford, FL, 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.

Oct 14, 2025 inspection

• Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
  The calibration of instruments, apparatus, gauges and recording devices is not done at suitable intervals in accordance with an established written program.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
• Enhanced systems - verification FDCA 582(g)(1)(C)
  Your firm failed to establish secure, interoperable, electronic systems for verification of product at the package level.

Aug 11, 2021 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Washing and toilet facilities are deficient 21 CFR 211.52
  Washing and toilet facilities lack hot and cold water.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
• Microbiological Contamination Exam 21 CFR 211.84(d)(6)
  Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.

May 18, 2018 inspection

• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful and specific test methods.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Laboratory equipment calibration records 21 CFR 211.194(d)
  Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
• 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.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the of a drug product are not maintained in a good state of repair.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Oct 6, 2014 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Stability sample storage conditions described 21 CFR 211.166(a)(2)
  The written stability program for drug products does not describe the storage conditions for samples retained for testing.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful and specific test methods.
• 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.
• Written record of investigation incomplete 21 CFR 211.192
  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.
• Laboratory equipment calibration records 21 CFR 211.194(d)
  Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.