Drug factory · FDA FEI 3002754162

Pure Source, LLC

9750 NW 17th St, Doral, FL, 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 14, 2019 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• 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.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Mar 1, 2018 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established and followed that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
• 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.
• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• 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.
• 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.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Feb 24, 2014 inspection

• Specifications - manufacturing process 21 CFR 111.70(a)
  You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
• 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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components, drug product containers, closures, in-process materials, and labeling conform to appropriate standards of identity, strength, quality and purity.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• 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.

Sep 22, 2011 inspection

• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
  Deviations from written production and process control procedures are not recorded and justified.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Sampling and testing plans not described 21 CFR 211.165(c)
  Sampling and testing plans for drug products are not described in written procedures which include the method of sampling.
• Sampling and testing plans not described 21 CFR 211.165(c)
  Sampling and testing plans for drug products are not described in written procedures which include the method of sampling.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not representative of each lot or batch of drug product.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of returned or salvaged drug products.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of returned or salvaged drug products.
• Identity of major equipment and lines used 21 CFR 211.188(b)(2)
  Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
• Identity of major equipment and lines used 21 CFR 211.188(b)(2)
  Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use and cleaning and maintenance.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use and cleaning and maintenance.
• Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
  Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
• Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
  Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

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