Drug factory · FDA FEI 1000160560

St. Mary's Medical Park Pharmacy

10860 N. Mavinee Dr, Oro Valley, 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.

Dec 4, 2025 inspection

• Absence of Written Procedures 21 CFR 211.100(a)
  Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
• Written calibration procedures 21 CFR 211.160(b)(4)
  Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
• Reserve samples identified, representative, stored 21 CFR 211.170(b)
  Reserve drug product samples are not appropriately identified and representative of each lot or batch of drug product.
• Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
  The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing, packing and holding.
• Written record of investigation incomplete 21 CFR 211.192
  Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.
• Lack of quality control unit 21 CFR 211.22(a)
  There is no quality control unit.
• 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.

Jul 27, 2016 inspection

• 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.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in current good manufacturing practices.

Registered with FDA for: relabel; repack.