Drug factory · FDA FEI 1000110364

Amgen Manufacturing Limited LLC

Carr 31 KM 24.6, Juncos, PR, 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 5, 2023 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Sample size - test intervals 21 CFR 211.166(a)(1)
  The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability.
• 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 free of infestation by rodents, birds insects, and other vermin.

Apr 11, 2019 inspection

• Quality Control Review 21 CFR 211.198(a)
  Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by 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.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Lack of or inadequate procedures 21 CFR 820.100(a)
  Procedures for corrective and preventive action have not been adequately established.
• Design verification - output does not meet input requirement 21 CFR 820.30(f)
  Design verification does not confirm that design output meets design input requirements.
• Purchasing controls, Lack of or inadequate procedures 21 CFR 820.50
  Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.

Aug 6, 2018 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.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that conform to appropriate standards of identity, strength, quality and purity.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into do not include the conclusions and follow-up.

May 10, 2017 inspection

• Review of representative number of batches 21 CFR 211.180(e)(1)
  Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
• Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
  Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.