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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 211.84(d)(3). Establish reliability of supplier's C of A Establishment of the reliability of the supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
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 conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.194(a)(2). Laboratory Test Method Verification Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use.
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 211.100(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 211.165(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 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified.
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.
Voluntary Action Indicated (VAI)
Jan 11, 2024
Drugs · Drug Quality Assurance
6 cited references
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 211.68(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 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.
21 CFR 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing, packing and holding.
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 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
Voluntary Action Indicated (VAI)
Apr 9, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Nov 29, 2010
Drugs · Drug Quality Assurance
19 cited references
21 CFR 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments, apparatus, and gauges is not done at suitable intervals in accordance with an established written program.
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 211.160(a). Deviations from laboratory control requirements Deviations from written test procedures are not recorded and justified.
21 CFR 211.194(a)(8). Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the of the second person reviewing the record for accuracy.
21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
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 211.194(a)(8). Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness.
21 CFR 211.160(b)(1). Determination of conformance Determinations of conformance to appropriate written specifications for acceptance are deficient in that they are not made for each lot within each shipment of components used in the manufacture, processing, packing or holding of drug products.
21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
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 211.67(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 211.22(a). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all in process materials, packaging material, and labeling.
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 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are not written or followed and deficiently written or followed.
21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
21 CFR 211.68(b). Written record not kept of program and validation data A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
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 211.165(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 211.188(b)(3). Identification of Components and In-Process Materials The batch production and control records are deficient in that they do not include specific identification of each batch of component used.
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
Commack, New York, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.