Drug factory · FDA FEI 3010892830

Nephron SC, LLC

4500 12th Street Extension, West Columbia, SC, 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 22, 2025 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  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.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review 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.
• Air Supply 21 CFR 211.42(c)(10)(iii)
  Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Sep 25, 2024 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
• 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.
• Floors, walls, ceiling surfaces 21 CFR 211.42(c)(10)(i)
  Aseptic processing areas are deficient in that are not smooth and/or hard surfaces that are easily cleanable.
• Air Supply 21 CFR 211.42(c)(10)(iii)
  Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Feb 9, 2024 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the sterilization process.
• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.

Feb 10, 2023 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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
• Retention time for reserve samples of actives 21 CFR 211.170(a)(1)
  Reserve samples of active drug ingredients are deficient in that they are not retained at least one year after the expiration date of the last lot of the drug containing the active drug ingredient.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• 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.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Air Supply 21 CFR 211.42(c)(10)(iii)
  Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
• Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
  Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

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