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FDA establishment 3004268965, Lake Oswego, Oregon, United States. Part of HTO Nevada, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 2
Last inspection ended: Aug 22, 2025
Warning letters: 1
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 211.180(e)(2). Items to cover on annual reviews Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.137(b). Storage conditions Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
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 211.100(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 211.84(d)(2). Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.122(b). Labeling and packaging improperly approved/released Labeling and packaging materials not meeting the appropriate written specifications were approved and released for use.
Official Action Indicated (OAI)
Mar 15, 2019
Drugs · Drug Quality Assurance
6 cited references
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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies.
21 CFR 211.166(a)(2). Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
Voluntary Action Indicated (VAI)
Apr 14, 2017
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jul 15, 2015
Drugs · Unapproved and Misbranded Drugs
2 cited references
21 CFR 111.70(b)(2). Specifications-component purity, strength, composition You did not establish component specifications for purity and strength.
21 CFR 111.70(e). Specifications - identity, purity, strength, composition You did not establish product specifications for the purity and strength of the finished dietary supplement.
Voluntary Action Indicated (VAI)
Jun 24, 2015
Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs
7 cited references
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection and checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.130. Procedures are written, and followed Procedures designed to assure that correct labels are used for drug products are not followed.
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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.28(a). Clothing appropriate for duties performed Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written, and followed.
Official Action Indicated (OAI)
Aug 6, 2013
Drugs · Drug Quality Assurance
15 cited references
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
21 CFR 211.188(b)(8). Labeling control records including specimens or copies Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product.
21 CFR 211.110(b). In-process materials specifications In-process specifications are not determined by the application of suitable statistical procedures where appropriate.
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 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining appropriate storage conditions.
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.
21 CFR 211.188(b)(7). Actual yield, % of theoretical yield The batch production and control records do not include a statement of the actual yield and percentage of theoretical yield at appropriate stages of processing for each batch of drug product produced.
21 CFR 211.186(b)(9). Complete instructions, procedures, specifications et. al. Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the receipt, sampling, approval, and rejection of components, drug product containers, and closures.
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(c). Cleaning/maintenance records not kept Records are not kept for the cleaning and sanitizing of equipment.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Voluntary Action Indicated (VAI)
Nov 22, 2011
Drugs · Drug Quality Assurance
14 cited references
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 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.22(b). Adequate lab facilities not available Adequate lab facilities for testing and approval or rejection of in-process materials and drug products are not available to the quality control unit.
21 CFR 211.186(b)(9). Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete manufacturing, control, instructions, sampling, testing, procedures, specifications, and precautions.
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 211.188(b)(5). In-process and laboratory control results Batch production and control records do not include in-process and laboratory control results for each batch of drug product produced.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established that describe the tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the sampling and testing of drug product containers and closures.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Lake Oswego, Oregon, United States. Part of