Findings
1Deviation, CAPA, and investigation
Your firm failed to ensure that returned drugs meet appropriate standards of safety, identity, strength, quality and purity prior to redistributing (21 CFR 211.204). Your firm’s handling of returned drug product before its redistribution is inadequate. For example, during the inspection, you were not able to provide documentation of adequate inspection and investigation of the returned product confirming the label conditions under which the returned drug product was held…
2Quality unit oversight
Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)). You failed to establish, review, and approve all procedures, including those which may impact the safety, identity, strength, quality, and purity of your drug product. Specifically, your QU failed to implement SOPs that are critical to ensure the quality of the drug product, such as the…
3Stability and storage
Your firm failed to follow a 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’s stability program is inadequate. Specifically, you only placed (b)(4) of your Super Colon Cleanse Stimulant Laxative drug product on stability and failed to perform any stability testing since at least September 2017…
4Quality 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 did not adequately validate the process used to manufacture your over-the-counter drug product Super…
5Laboratory and QC controls
Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You did not adequately validate the method for assay used for your Super Colon Cleanse laxative drug product release specification. Specifically, per your specifications, the (b)(4) Spectrophotometer method for assay is to be conducted at the wavelength of (b)(4) as indicated in your finished drug product specifications. However…
About this record
Extracted automatically from the document US FDA published on 2022-01-25. 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.
