Drug factory · FDA FEI 3000209995

American Health Packaging

2550 John Glenn Ave, Columbus, OH, 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 15, 2017 inspection

• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• 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.
• 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.

Sep 10, 2012 inspection

• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
• Status of Each Lot Identified 21 CFR 211.80(d)
  Each lot of components, drug product containers, and closures was not appropriately identified as to its status in terms of being quarantined, approved or rejected.

Jul 16, 2010 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.
• SOPs not followed / documented 21 CFR 211.100(b)
  Written production and process control procedures are not followed in the execution of production and process control functions.
• Labeling and packaging improperly approved/released 21 CFR 211.122(b)
  Labeling and packaging materials not meeting the appropriate written specifications were approved and released for use.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, and parameters relevant to the operation.

Registered with FDA for: analysis; label; repack.