Drug factory · FDA FEI 3011632

Pascal Company, Inc.

2929 Northup Way, Bellevue, 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.

Aug 21, 2025 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• 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 drug products conform to appropriate standards of identity, strength, quality and purity.
• 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 system access limitation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Feb 25, 2013 inspection

• 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.
• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
• Lab controls established, including changes 21 CFR 211.160(a)
  The establishment of specifications including any changes thereto, are not drafted by the appropriate organizational unit and 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 sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include reliable and meaningful test methods.
• Adequate lab facilities not available 21 CFR 211.22(b)
  Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.
• 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 cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Documentation 21 CFR 820.100(b)
  Corrective and preventive action activities and/or results have not been adequately documented.
• Lack of or inadequate complaint procedures 21 CFR 820.198(a)
  Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
• Investigation of device failures 21 CFR 820.198(c)
  Complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.
• Sampling plans 21 CFR 820.250(b)
  Sampling plans are not based on valid statistical rationale.
• Design input - documentation 21 CFR 820.30(c)
  Design input requirements were not adequately documented.
• Design validation - documentation 21 CFR 820.30(g)
  The results of design validation, including method(s), were not adequately documented in the design history file.
• Design validation- Lack of or inadequate procedures 21 CFR 820.30(g)
  Procedures for design validation have not been adequately established.
• Evaluation of suppliers, contractors, etc., requirements 21 CFR 820.50(a)
  Requirements that must be met by suppliers and contractors have not been adequately established.
• Process control procedures, Lack of or inadequate procedures 21 CFR 820.70(a)
  Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
• Lack of or inadequate process validation 21 CFR 820.75(a)
  A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• Procedures for product review,disposition lack of/inadequate 21 CFR 820.90(b)(1)
  Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been established.

Registered with FDA for: manufacture.