Drug factory · FDA FEI 3011557028

Proficient Rx LP

3607 Old Conejo Road, Thousand Oaks, CA, 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.

Oct 22, 2015 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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.
• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which 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.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established 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.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established 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.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• No written record of investigation 21 CFR 211.192
  Written records are not always made of investigations into unexplained discrepancies.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer are not checked for accuracy.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer are not checked for accuracy.

Registered with FDA for: label; relabel; repack.