Drug factory · FDA FEI 2016096

Apotheca Inc.

1622 N 16 Street, Phoenix, AZ, 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 11, 2017 inspection

• 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.
• 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.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
• Procedures to be written and followed 21 CFR 211.198(a)
  Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration and inspection of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Jan 29, 2009 inspection

• Written records kept in individual logs 21 CFR 211.182
  Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs.
• Identity of major equipment and lines used 21 CFR 211.188(b)(2)
  Batch production and control records do not include the identity of individual major equipment and lines used for each batch of drug product produced.
• Penicillin processing area not kept separate 21 CFR 211.42(d)
  The operations relating to the packing of penicillin are not performed in facilities separate from those used for other drug products for human use.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use and cleaning and maintenance.
• 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.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, and description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.

Registered with FDA for: manufacture; relabel; repack.