Drug factory · FDA FEI 3003407422

Syntho Pharmaceuticals Inc.

230 Sherwood Ave., Farmingdale, NY, 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 3, 2019 inspection

• In-process specification, invalid 21 CFR 211.110(b)
  Your in-process specifications for sampling and testing of in-process materials and drug products were inconsistent with drug product final specifications and were not determined by the application of suitable statistical procedures.
• 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.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures are not followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
• Test devices not meeting specifications 21 CFR 211.160(b)(4)
  Test devices are deficient in that instruments and recording devices not meeting established specifications are used.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
• Annual visual exams of drug products 21 CFR 211.170(b)
  Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.
• 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.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
• Written Procedures Not Followed 21 CFR 211.80(a)
  Written procedures are not followed for the testing and approval of components.

Aug 26, 2016 inspection

• Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
  Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
• 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 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.
• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not consistent with drug product final specifications, derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate.
• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
• Reprocessing procedures not written or followed 21 CFR 211.115(a)
  Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
• 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.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures are not followed.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of sampling plans including any changes thereto, are not reviewed and approved by the quality control unit.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Establishment of calibration procedures 21 CFR 211.160(b)(4)
  Procedures describing the calibration of instruments, apparatus, gauges and recording devices are.
• Test devices not meeting specifications 21 CFR 211.160(b)(4)
  Test devices are deficient in that instruments and recording devices not meeting established specifications are used.
• Failing drug products not rejected 21 CFR 211.165(f)
  Drug products failing to meet established specifications are not rejected.
• Adequate number of batches on stability 21 CFR 211.166(b)
  An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
• Dedicated equipment: records part of batch record 21 CFR 211.182
  The records of use for dedicated equipment are not part of the batch record.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
• 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.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in written procedures required by current good manufacturing practice regulations.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• 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.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
• Written Procedures Not Followed 21 CFR 211.80(a)
  Written procedures are not followed for the testing and approval of components.
• 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.

Aug 23, 2013 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.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Establishment of time limitations 21 CFR 211.111
  Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
• Drug product reserve containers 21 CFR 211.170(b)
  Drug product reserve samples are not stored in the same immediate container-closure system as the marketed product.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not appropriately identified and representative of each lot or batch of drug product.
• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

Registered with FDA for: manufacture.