Findings
1Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). You failed to demonstrate that your (b)(4) system can consistently meet the minimum USP monograph…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). You failed to test incoming active pharmaceutical ingredients (API) used to manufacture your drug products to determine their identity. Instead, our investigator observed that your firm released (b)(4) API for use in manufacturing without an identification test for (b)(4) . Identity testing is required for each component lot prior to use in drug…
3Process validation
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. Your firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)). Lack of process validation You failed to provide data to demonstrate that the…
4Data integrity
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). You failed to have adequate controls in place for your Fourier Transform Infrared Spectrometer (FTIR) system. For example, you did not establish unique usernames and passwords for each analyst. In addition, the audit trail function was disabled even though…
About this record
Extracted automatically from the document US FDA published on 2022-09-27. 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.
