Drug factory · FDA FEI 3005391759

Pharmalogic South Carolina, LLC

1185 Woods Chapel Rd, Duncan, SC, 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.

Jun 28, 2019 inspection

• Determination need for investigation 21 CFR 212.20(d)
  When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary.

Nov 3, 2011 inspection

• Actual vs. theoretical yields not determined 21 CFR 211.103
  Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, and holding of the drug product.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
• In-process materials specifications 21 CFR 211.110(b)
  In-process specifications are not determined by the application of suitable statistical procedures where appropriate.
• In-process materials characteristics testing 21 CFR 211.110(c)
  In-process materials are not tested for identity, strength, quality, and purity and approved or rejected by the quality control unit during the production process.
• Written procedures describing in detail 21 CFR 211.122(a)
  There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and testing of labeling and packaging materials.
• Examinations documented 21 CFR 211.134(c)
  The results of the examination of the packaged and labeled products were not documented in the batch production or control records.
• Quarantine - actual practice 21 CFR 211.142(a)
  Drug products are not quarantined before being released 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 specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality and purity.
• 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.
• 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 and number of units per batch to be tested.
• Lack of written stability program 21 CFR 211.166(a)
  There is no written testing program designed to assess the stability characteristics of drug products.
• Specific information required in individual logs 21 CFR 211.182
  Individual equipment logs do not show date, product, and lot number of each batch processed.
• Individual inventory record 21 CFR 211.184(c)
  Records fail to include an individual inventory record of each component, reconciliation of the use of each component, drug product container, and drug product closure with sufficient information to allow determination of any associated batch or lot of drug product.
• Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
  The master production and control records are deficient in that they do not include complete manufacturing, control, instructions, sampling, procedures, and specifications.
• 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 used for each batch of drug product produced.
• Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
  Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
• Complete test data included in records 21 CFR 211.194(a)
  Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
• 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.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, instructions for protection of clean equipment from contamination prior to use, and parameters relevant to the operation.
• 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 calibration / inspection records not kept 21 CFR 211.68(a)
  Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
• Identity Testing of Each Component 21 CFR 211.84(d)(1)
  The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
• 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.
• Testing Containers & Closures Conformity with Specs 21 CFR 211.84(d)(3)
  Containers and closures are not tested for conformance with all appropriate written procedures.

Registered with FDA for: positron emission tomography drug production.