Findings
1Process 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 (21 CFR 211.100(a)). Your firm failed to conduct process validations for all your over-the-counter (OTC) drug products, including but not limited to your (b)(4) products. Our investigators also found three instances of bulk lot (b)(4)…
2Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You lacked the cleaning validation studies required by your written procedures for OTC drug products. You failed to demonstrate your cleaning practices are adequate to remove potential contaminants and to prevent product carry over in shared equipment (for example, fillers and small utensils used for formulation) used to manufacture your OTC drug…
3Quality unit oversight
Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22 (d)). You lacked adequate quality unit (QU) oversight for the manufacture of your OTC drug products. For example: You have not performed an annual product review (APR) of your OTC drug products manufactured since 2022. You failed to follow your procedure for raw material sampling, in that multiple different…
4Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21CFR 211.84(d)(1). Your firm failed to adequately test your incoming components for identity before using the components to manufacture your OTC drug products. Specifically, your firm did not perform identity testing for the following raw materials: (b)(4) , which are used in the production of (b)(4) batch (b)(4) . We also note that you use raw material (b)(4) to…
About this record
Extracted automatically from the document US FDA published on 2025-12-16. 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.
