Drug factory · FDA FEI 3004582966

Preferred Pharmaceuticals Inc.

1250 N. Lakeview Ave. Suite O, Anaheim, 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.

May 27, 2025 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.
• 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.

Jan 14, 2020 inspection

• Written in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
• 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, of adequate size and suitably located to facilitate operations for its intended use.

Oct 29, 2015 inspection

• Review of problem drugs 21 CFR 211.180(e)(2)
  The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of complaint, recall, returned drug product, salvaged drug product, and investigation records for each drug product.
• Record information inclusions 21 CFR 211.204
  Records of returned drug products do not include the name, labeled potency, lot, control or batch number, and quantity.
• 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, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
• Protective Apparel Not Worn 21 CFR 211.28(a)
  Protective apparel is not worn as necessary to protect drug products from contamination.
• Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
  Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Dec 30, 2009 inspection

• Packaging line inspection before use 21 CFR 211.130(e)
  Inspection of the facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
• 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.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: relabel; repack.