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FDA establishment 2022194, Santa Fe Springs, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 1
Last inspection ended: Oct 30, 2024
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of processing and packaging of the drug product.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish 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 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include reliable and meaningful test methods.
21 CFR 211.22(a). Authority lacking to review records, investigate errors The quality control unit lacks authority to review production records to assure that no errors have occurred.
Voluntary Action Indicated (VAI)
Oct 26, 2023
Drugs · Drug Quality Assurance
11 cited references
21 CFR 211.84(a). Components withheld from use pending release Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing and packaging of the drug product.
21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized 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). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all components and drug products.
21 CFR 211.184(c). Individual inventory record Records fail to include an individual inventory record of each reconciliation of the use of each component with sufficient information to allow determination of any associated batch or lot of drug product.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish 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 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
Official Action Indicated (OAI)
Aug 23, 2019
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
21 CFR 211.165(f). Failing drug products not rejected Drug products failing to meet established specifications are not rejected.
21 CFR 211.115(a). Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.
Voluntary Action Indicated (VAI)
Feb 16, 2017
Drugs · Drug Quality Assurance
12 cited references
21 CFR 211.194(a)(4). Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs and spectra from laboratory instrumentation, properly identified to show the in-process material and drug product tested. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
21 CFR 211.186(a). Written procedures followed Procedures for the preparation of master production and control records are not followed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in written procedures required by current good manufacturing practice regulations.
21 CFR 211.160(a). Lab controls established, including changes The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
21 CFR 211.142. Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not established and followed.
21 CFR 211.84(d)(1). Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
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. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
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 Fe Springs, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.