Findings
1Equipment and facility
Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58). You failed to maintain your over-the-counter (OTC) drug manufacturing facility in a good state of repair. Our investigator observed paint peeling from the floor, and windows that were cracked and repaired with tape. In addition, vents and light fixtures above tablet presses were covered in white powder. It is essential…
2Process 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. Your firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)). Lack of process validation You failed to validate your processes and qualify the…
3Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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)). You failed to conduct any test to confirm the identity of incoming raw materials. For example, you stated sodium fluoride, which is the active…
4Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). You failed to perform release testing of batches of Kaylaan Toothpaste Tablets with Fluoride. During the inspection, you stated no finished product release testing was conducted for identity and strength of…
5Quality unit oversight
Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). You lacked a quality unit (QU) with appropriate oversight for the manufacture of your drug products, and you did not have written quality procedures. For example, you failed to ensure the following: Each person engaged in the manufacture, processing, packing, or holding of…
About this record
Extracted automatically from the document US FDA published on 2024-09-03. 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.
