US FDAPublished 2024-08-065 findingsDeviation, CAPA, and investigationContamination controlQuality unit oversightMaterial and supplier controlStability and storage
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) failed to have adequate procedures, documentation, and practices to properly exercise its functions. For example, deviations were not recorded, and investigations were not conducted when microbiological test results were…
2Contamination control
Your firm failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)). Your firm failed to adequately establish and follow procedures to prevent objectionable microorganisms in your combination product. Your firm released and distributed multiple batches of (b)(4) that exceeded the limits for total aerobic plate count. During our inspection, your Head of Quality stated that…
3Quality unit oversight
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)). Your firm failed to provide data to demonstrate you have validated the manufacturing process for (b)(4) and…
4Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 221.84 (d)(2)). Your firm failed to perform adequate testing of incoming raw materials including active pharmaceutical ingredients and high-risk components such as glycerin. Your firm released glycerin for use in manufacturing based on a component supplier’s analysis report, although you had not…
5Stability and storage
Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug product and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm did not provide adequate stability data to demonstrate that the chemical and microbiological characteristics of (b)(4) remained acceptable throughout its labeled expiry period of (b)(4) . During the inspection…
About this record
Extracted automatically from the document US FDA published on 2024-08-06. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
