FDA establishment 2020223, Paramount, California, United States. Part of DLC Laboratories, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
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.
Voluntary Action Indicated (VAI)
Dec 12, 2019
Drugs · Drug Quality Assurance
8 cited references
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.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
21 CFR 211.192. No written record of investigation Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
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 performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
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 211.188(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 manufacturing, processing, packing and holding.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.134(b). Representative samples after completion Samples of representative units were not visually examined for correct labeling at the completion of finishing operations.
Voluntary Action Indicated (VAI)
Mar 30, 2018
Drugs · Drug Quality Assurance
4 cited references
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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.
Voluntary Action Indicated (VAI)
Dec 11, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
May 3, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Aug 3, 2011
Drugs · Drug Quality Assurance
1 cited reference
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.
Voluntary Action Indicated (VAI)
Sep 21, 2010
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
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