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21 CFR 211.180(e)(1). Review of representative number of batches Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
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 211.67(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 211.165(d). Acceptance criteria for sampling & testing Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.
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 211.160(b)(4). Written calibration procedures Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules and limits for accuracy and precision.
21 CFR 211.67(b)(1). Cleaning SOP/responsibility Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.
21 CFR 211.184(d). Labeling: documentation of exam and review There is no documentation of the examination and review of labels and labeling for conformity with established specifications.
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 and cleaning and maintenance.
Official Action Indicated (OAI)
Jul 21, 2017
Drugs · Drug Quality Assurance
6 cited references
21 CFR 211.170(b). Reserve samples identified, representative, stored Reserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
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 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
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 identity and strength of each active ingredient prior to release.
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.
Voluntary Action Indicated (VAI)
Dec 11, 2015
Drugs · Drug Quality Assurance
10 cited references
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 211.63. 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 211.192. 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 211.84(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 211.196. Distribution Record Requirements Distribution records do not contain the lot or control number of drug product.
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, returned or salvaged drug products, and investigations conducted for each drug product.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.100(a). Changes to Procedures Not Reviewed, Approved Changes to written procedures are not reviewed and approved by the quality control unit.
21 CFR 211.160(b)(4). Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
Voluntary Action Indicated (VAI)
Dec 9, 2011
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.188(a). Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
21 CFR 211.160(a). Following/documenting laboratory controls Established specifications and laboratory control mechanisms are not followed and documented at the time of performance.
21 CFR 211.165(c). Sampling and testing plans not described Sampling and testing plans for drug products are not described in written procedures which include the method of sampling and number of units per batch to be tested.
21 CFR 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Voluntary Action Indicated (VAI)
Nov 10, 2010
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.165(c). Sampling and testing plans not described Sampling and testing plans for drug products are not described in written procedures which include the method of sampling and number of units per batch to be tested.
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, returned or salvaged drug products, and investigations conducted for each drug product.
21 CFR 211.188(b)(2). Identity of major equipment and lines used Batch production and control records do not include the identity of individual major equipment used for each batch of drug product produced.
21 CFR 211.160(a). Lab controls established, including changes The establishment of specifications, standards, sampling plans, test procedures, and laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
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.
Voluntary Action Indicated (VAI)
Mar 12, 2009
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
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
Chino, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.