Drug factory · FDA FEI 3005336862

Apace Packaging LLC

12954 Fountain Run Road, Fountain Run, KY, 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 4, 2016 inspection

• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

Sep 23, 2011 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.
• Written procedures not followed 21 CFR 211.122(a)
  Written procedures for the receipt and storage of packaging and labeling materials are not followed.
• Rejection of unapproved labeling/packaging materials 21 CFR 211.122(b)
  Labeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they are unsuitable.
• Examination of issued labels 21 CFR 211.125(b)
  Labeling materials issued for a batch were not carefully examined for identity and conformity to the labeling specified in the master or batch production records.
• 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.
• Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
  Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling.
• Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
  Master production and control records lack complete manufacturing and control instructions.
• 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.
• 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.
• Approve or reject procedures or specs 21 CFR 211.22(c)
  The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity and quality of drug products.
• 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.
• 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.
• Exhaust systems inadequate to control air contamination 21 CFR 211.46(c)
  Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration, inspection, and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
• 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.

Registered with FDA for: label; pack; relabel; repack.