Drug factory · FDA FEI 1019820

Crown Laboratories

349 Lafe Cox Drive, Johnson City, TN, 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.

Sep 19, 2025 inspection

• 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.

Apr 8, 2016 inspection

• Electronic records 21 CFR 11
  Electronic records are used, but they do not meet system access limitation , audit trail and signature to record linking requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Data secured in course of each test 21 CFR 211.194(a)(4)
  Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs and spectra from laboratory instrumentation, properly identified to show the specific component and in-process material.
• Complaint Handling Procedure 21 CFR 211.198(a)
  Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
• Late submission 21 CFR 310.305(c)(1)(i)
  Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial receipt of the information.
• Failure of responsible person to report AE (non-RX Drug) FDCA 760(b)(1)
  Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary.

Feb 14, 2014 inspection

• Control procedures fail to include the following 21 CFR 211.110(a)
  Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
• Control procedures fail to include the following 21 CFR 211.110(a)
  Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
• Procedures are written, and followed 21 CFR 211.130
  Procedures designed to assure that correct labeling and packaging materials are used for drug products are not followed.
• Procedures are written, and followed 21 CFR 211.130
  Procedures designed to assure that correct labeling and packaging materials are used for drug products are not followed.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not documented at the time of performance.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not documented at the time of performance.
• Test methods 21 CFR 211.165(e)
  The sensitivity of test methods have not been documented.
• Test methods 21 CFR 211.165(e)
  The sensitivity of test methods have not been documented.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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.
• 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.

Mar 9, 2012 inspection

• Control procedures fail to include the following 21 CFR 211.110(a)
  Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
• 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.
• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Acceptance criteria for sampling & testing 21 CFR 211.165(d)
  Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
• 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 maintained in a clean and sanitary condition.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
• Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
  There was a failure to handle and store components at all times in a manner to prevent contamination.

Registered with FDA for: label; manufacture; pack.