Drug factory · FDA FEI 3001238690

Massco Dental

1506 N 2nd Street, Rogers, AR, 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 2, 2022 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and 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.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
• Microbiological testing 21 CFR 211.165(b)
  Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Component identification test 21 CFR 211.84(d)(2)
  Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Aug 18, 2016 inspection

• Identification of containers, lines, equipment 21 CFR 211.105(a)
  All used during the production of a batch of drug product is not properly identified at all times to indicate.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Jul 18, 2014 inspection

• 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.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in.
• Identification of Equipment and Lines 21 CFR 211.188(b)(2)
  The batch production and control records are deficient in that they do not include the identity of major equipment used.
• Calculations performed are in the records 21 CFR 211.194(a)(5)
  Laboratory records do not include a record of all calculations performed in connection with the test.

Oct 29, 2010 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.
• Drug products-sampling procedures/specifications 21 CFR 211.160(b)(3)
  Laboratory controls do not include a determination of conformance to appropriate specifications for drug products.
• Sample size - test intervals 21 CFR 211.166(a)(1)
  The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability.
• Labeling: documentation of exam and review 21 CFR 211.184(d)
  There is no documentation of the examination and review of labels and labeling for conformity with established specifications.
• 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.
• 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.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Registered with FDA for: manufacture.