Yusef Manufacturing Laboratories, LLC — FDA Warning Letter Findings
US FDAPublished 2022-04-125 findingsStability and storageProcess validationDeviation, CAPA, and investigationMaterial and supplier controlLaboratory and QC controls
Your firm failed to follow 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 does not have adequate stability data to show that the chemical and microbiological properties of your drug products remain acceptable throughout the labeled expiry period of three years. During the inspection, you…
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)). You failed to adequately validate your manufacturing processes used to manufacture your drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and…
3Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your investigations into out-of-specification (OOS) laboratory results are incomplete, do not include scientifically supported conclusions, and lack adequate CAPA. For example, while testing SPF30 Lip Balm Sunscreen batch (b)(4) , you obtained a failing…
4Material 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 (2)) You failed to adequately test your incoming components for identity before using the components to manufacture your over-the-counter (OTC) drug products. Additionally, you relied on certificates of analysis…
5Laboratory 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)). You lacked analytical instrumentation and suitable test methods to test your ethanol-based hand…
About this record
Extracted automatically from the document US FDA published on 2022-04-12. 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.
