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FDA establishment 3008563008, Lenoir, North Carolina, United States. Part of Exela Pharma Sciences's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 12
Official action indicated: 1
Last inspection ended: Nov 15, 2024
Warning letters: 1
Recalls since 2016: 8
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.94(c). Containers & Closures Clean, Sterilized, Pyrogen-free Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance 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.
Voluntary Action Indicated (VAI)
Dec 19, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Sep 11, 2018
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Sep 28, 2017
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store components and drug product containers at all times in a manner to prevent contamination.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
FDCA 503B(a)(10). Drug product label, outsourcer facility The labels of your outsourcing facility's drug products are deficient.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.134(c). Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
Voluntary Action Indicated (VAI)
Jun 8, 2016
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Nov 21, 2014
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Aug 28, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Apr 12, 2013
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jan 20, 2012
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Sep 2, 2011
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Dec 10, 2010
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Lenoir, North Carolina, United States. Part of