Findings
1Complaint and recall handling
Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)). You lacked adequate oversight for the manufacture and repackaging of your OTC drug products. For example, you failed to ensure: Establishment of suitable quality oversight procedures (e.g., investigations, returns/complaints, CAPA, and label reconciliation)…
2Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture your OTC drug products. Inadequate Cleaning Validation Your 2009 cleaning validation study for the Kettle (b)(4) equipment is inadequate to ensure your cleaning procedures are effective for the multiple OTC drug…
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm manufactures and repackages over-the-counter (OTC) drug products, including topical liquids and ointments, without adequate assurance of the quality of components used in their manufacture…
4Process 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)). You failed to demonstrate you adequately validated the manufacturing processes for your OTC drug products. You stated that you validated the process for (b)(4) Sunscreen, (b)(4) SPF 30, (b)(4) SPF 30, and End Zit Acne Drying…
About this record
Extracted automatically from the document US FDA published on 2025-08-12. 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.
