Drug factory · FDA FEI 3008563008

Exela Pharma Sciences, LLC.

1245 Blowing Rock Blvd. 1325 William White Place 320 Cooperative Way 2101 Morganton Blvd 1201 Exela Way 1170 West Ave NW, Lenoir, NC, 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.

Jul 18, 2019 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 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 adequate validation of the aseptic process.
• Prepared for each batch, include complete information 21 CFR 211.188
  Batch production and control records do not include complete information relating to the production and control of each batch.
• 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.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Containers & Closures Clean, Sterilized, Pyrogen-free 21 CFR 211.94(c)
  Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Sep 28, 2017 inspection

• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Examinations documented 21 CFR 211.134(c)
  The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components and drug product containers at all times in a manner to prevent contamination.
• Drug product label, outsourcer facility FDCA 503B(a)(10)
  The labels of your outsourcing facility's drug products are deficient.

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