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 211.165(f). Failing drug products not rejected Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices.
21 CFR 211.130(a). Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
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 211.113(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.
21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
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.
Voluntary Action Indicated (VAI)
Apr 9, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Aug 26, 2016
Drugs · Drug Quality Assurance
2 cited references
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 complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not followed 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)
Aug 16, 2012
Drugs · Drug Quality Assurance
21 cited references
21 CFR 111.123(a)(7). Quality control operations - finished batch, specifications Your quality control operations did not include determining whether each finished batch conforms to established product specifications.
21 CFR 111.160(e). Packaging, labels - mix-ups You did not hold labels under conditions that will avoid mix-ups.
21 CFR 111.165(c)(2). Product received - quality control; documentation; specs Your quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications.
21 CFR 111.30(c). Equipment - automated - calibrate, inspect You did not routinely calibrate the automated, mechanical, or electronic equipment to ensure proper performance.
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 211.182. Personnel dating/signing equipment log The persons double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
21 CFR 111.260(j)(2)(ii). Batch record - initials; verifying weight Your batch production records did not include the initials of the person responsible for verifying the weight or measure of each component used in the batch.
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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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 111.75(a)(1)(i). Component - verify identity, dietary ingredient You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
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.
21 CFR 111.14(b)(2). Personnel - records - training You did not make and keep documentation of training.
21 CFR 211.192. Written record of investigation incomplete Written records of investigations into the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.
21 CFR 111.205(a). Master manufacturing record - each batch You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
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 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 111.25(c). Procedures - equipment - cleaning, sanitizing You did not establish and follow written procedures for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 111.30(b). Equipment - automated - suitability You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring that the equipment is capable of operating satisfactorily within the operating limits required by the process.
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, returned or salvaged drug products, and investigations conducted for each drug product.
21 CFR 111.60(a). Production, in- process control system - design, quality Your production and in-process control system is not designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement.
Voluntary Action Indicated (VAI)
Aug 12, 2010
Drugs · Drug Quality Assurance
8 cited references
21 CFR 111.553. Written procedures - product complaint You did not follow written procedures for the requirements to review and investigate a product complaint.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions 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 111.75(a)(1)(i). Component - verify identity, dietary ingredient You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include parameters relevant to the operation.
21 CFR 111.75(i). Corrective action plan You did not establish a corrective action plan to use when an established specification is not met.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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 111.365(a). Conditions, controls -protect; microorganisms, contamination You did not perform manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination.
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Carrollton, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.