Drug factory · FDA FEI 3005372033

Unit Dose Solutions, Inc.

2405 Alwin Ct, Ste 100, Raleigh, NC, 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, 2026 inspection

• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing.
• Quarantine of Rejected Components et. al. 21 CFR 211.89
  Rejected components, drug product containers and closures are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

Jul 23, 2015 inspection

• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints and investigations conducted for each drug product.
• 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.
• GMP Training Frequency 21 CFR 211.25(a)
  GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

Dec 19, 2011 inspection

• Storage under appropriate conditions 21 CFR 211.142(b)
  Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
• Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
  All records of production and control associated with a batch of drug product are not maintained at least one (1) year after the expiration date.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
• Responsible firm officials notified in writing 21 CFR 211.180(f)
  Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of investigations conducted.
• Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
  Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
• 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.
• 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 established and written.
• Record information maintained 21 CFR 211.204
  Records of returned drug products are not maintained.

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