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FDA establishment 3002998723, Santa Rosa, California, United States. Part of NeilMed Pharmaceuticals Inc's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 2
Last inspection ended: Jul 22, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing and packing of a drug product lack the training and experience required to perform their assigned functions.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not followed.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Voluntary Action Indicated (VAI)
May 8, 2024
Drugs · Drug Quality Assurance
9 cited references
21 CFR 211.188(b)(8). Labeling Control Records and Label Copies The batch production and control records are deficient in that they do not include complete labeling control records, specimen and copy of labeling.
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications are not rejected.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Official Action Indicated (OAI)
Dec 2, 2022
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.84(d)(1). Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Santa Rosa, California, United States. Part of