Drug factory · FDA FEI 2513595

Medical Products Laboratories, Inc.

9990 Global Road, Philadelphia, PA, 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 13, 2023 inspection

• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Jul 21, 2015 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 and documented at the time of performance.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components and drug product containers are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

Feb 24, 2014 inspection

• Product complaint - quality control review 21 CFR 111.560(a)(1)
  A qualified person did not review a product complaint to determine whether the product complaint involves a possible failure of a dietary supplement to meet specifications or any other requirements.
• 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.
• 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.
• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Valid stability test methods 21 CFR 211.166(a)(3)
  The written stability program for drug products does not include meaningful test methods.
• Extent of discrepancy, failure investigations 21 CFR 211.192
  Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
• 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.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained 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 description in sufficient detail of methods, equipment and materials used.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
• Production processes 21 CFR 820.70(a)
  Production processes were not controlled to ensure that a device conforms to its specifications.

Apr 27, 2011 inspection

• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.

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