Drug factory · FDA FEI 1000187727

Cammack's Pharmacies, Inc. dba Jim's Pharmacy

424 E 2nd St, Port Angeles, 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.

May 9, 2012 inspection

• Quarantine - actual practice 21 CFR 211.142(a)
  Drug products are not quarantined before being released by the quality control unit.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established test procedures are not followed.
• 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.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• 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.
• 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.
• Components withheld from use pending release 21 CFR 211.84(a)
  Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

Apr 8, 2011 inspection

• Approval and review of procedures 21 CFR 211.100(a)
  Written procedures are not reviewed and approved by the quality control unit.
• 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.
• 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, and examination of labeling and packaging materials.
• Procedures Written and Followed 21 CFR 211.125(f)
  Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.
• Procedures are written, and followed 21 CFR 211.130
  Procedures designed to assure that correct labels are used for drug products are not written.
• Written distribution procedure 21 CFR 211.150
  Written distribution procedures are not established.
• Testing and release for distribution 21 CFR 211.165(a)
  Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
• Test methods 21 CFR 211.165(e)
  The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
• Written procedures followed 21 CFR 211.186(a)
  Procedures for the preparation of master production and control records are not described in a written procedure.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• Laboratory equipment calibration records 21 CFR 211.194(d)
  Laboratory records do not include complete records of the periodic calibration of laboratory instruments and gauges.
• 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 written.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
• Supervisor Training/Education/Experience 21 CFR 211.25(b)
  Individuals responsible for supervising the manufacture, processing, packing, and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components.

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