Findings
1Material 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)). Based on the records and information you provided, you have not demonstrated that you conduct at least one test to verify the identity of each component of a drug product. For example, your response to our initial 704(a)(4) request for information on identity testing for each lot of component indicates that you conduct an organoleptic examination or…
2Laboratory 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)). Our review of the COAs you provided for batches shipped to the United States indicate that you…
3Documentation and records
Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)). The batch records you provided in response to our request for records lacked adequate production details, including, but not limited to, identity of major equipment, duration of execution of each significant step, total…
About this record
Extracted automatically from the document US FDA published on 2022-03-29. 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.
