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)). Your firm had inadequate laboratory controls. For example: Microbiological methods used for…
2Process validation
Your firm failed to establish 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. (21 CFR 211.100(a)). Your firm failed to provide data to demonstrate that you have validated manufacturing processes for your over-the-counter (OTC) drug products, including but not limited to “Rhinase D.” Your firm lacked qualification…
3Stability and storage
Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates. (21 CFR 211.166(a)). Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the OTC drug products that you manufacture. For example, you assigned a five-year expiry period to “Rhinase D”…
4Quality unit oversight
Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)). You lacked testing for every shipment of every lot of components used in the manufacture of your drug products. Specifically, you lacked a specific identity test to detect diethylene glycol (DEG) and ethylene glycol (EG) in all shipments…
5Equipment and facility
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). Your purified water system used to manufacture drug products was not designed and maintained appropriately for its intended use. For example, your water system included a dead leg and was not continuously…
About this record
Extracted automatically from the document US FDA published on 2023-03-14. 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.
