Drug factory · FDA FEI 1619076

Calvin Scott & Co., Inc.

209 Eubank Blvd., NE, Albuquerque, NM, 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 19, 2023 inspection

• 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 recalls, returned or salvaged drug products and investigations conducted for each drug product.
• 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.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in current good manufacturing practices.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• 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.

Dec 2, 2021 inspection

• Strict control not exercised over labeling issued 21 CFR 211.125(a)
  Strict control is not exercised over labeling issued for use in drug product labeling operations.
• Packaging line inspection after use 21 CFR 211.130(e)
  Inspection of the labeling facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.
• Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
  All records of production, control and labeling associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established and 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.
• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment use are not included in individual equipment logs.
• Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
  Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
• 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.
• 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.

Jun 18, 2021 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.
• 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.
• 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.
• 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 and current good manufacturing practices.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Mar 12, 2020 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.
• 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 and followed.
• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
• Representative samples after completion 21 CFR 211.134(b)
  Samples of representative units were not collected and visually examined for correct labeling at the completion of finishing operations.
• 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.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no 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 in writing and fully followed.
• Excluding Employees with Illness, Lesions 21 CFR 211.28(d)
  Employees with apparent illness are not excluded from direct contact with components, drug product containers, closures and drug products until the condition is determined by competent medical personnel not to jeopardize the safety or quality of drug products.
• Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
  Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: repack.