Drug factory · FDA FEI 3010477

Jubilant HollisterStier LLC

3525 N. Regal Street, Spokane, WA, 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.

Jul 31, 2015 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Apr 15, 2014 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.
• Mixing adequacy 21 CFR 211.110(a)(3)
  The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
• 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 drug products conform to appropriate standards of identity, strength, quality and purity.
• Drug product sample 21 CFR 211.160(b)(3)
  Drug product samples are not representative of the entire batch.
• Drug products - samples representative, identified properly 21 CFR 211.160(b)(3)
  Samples taken of drug products for determination of conformance to written specifications are not representative.
• 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.
• Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
  Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
• Complete Test Data 21 CFR 211.194(a)(4)
  Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
• 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.
• Signatures and dates--person who performs test 21 CFR 211.194(a)(7)
  Laboratory records do not include the date(s) the tests were performed.
• 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.
• 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 the particular operations they perform as part of their function.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
• Computer control of master formula records 21 CFR 211.68(b)
  Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet systems validation, system access limitation, audit trail, and signature to record linking requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the receipt, storage, handling, testing, approval, and rejection of components.
• Lab written procedures 21 CFR 212.60(f)
  Laboratory written procedures are not followed to ensure that the lab equipment is routinely calibrated.

May 10, 2013 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.
• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the 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 consistent with drug product final specifications and derived from previous acceptable process average and process variability estimates where possible.
• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established laboratory control mechanisms are not followed.
• Written program not followed 21 CFR 211.166(a)
  The written stability testing program is not followed.
• Stability sample storage conditions described 21 CFR 211.166(a)(2)
  The written stability program for drug products does not describe the storage conditions for samples retained for testing.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
• 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.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
  Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
• Cleaning System 21 CFR 211.42(c)(10)(v)
  Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.

May 8, 2009 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
• Validation lacking for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
• Documentation of Sampling Performed 21 CFR 211.188(b)(10)
  The batch production and control records are deficient in that they do not include documentation of sampling performed.
• Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
  Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

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