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FDA establishment 1053442, Asheville, North Carolina, United States. Part of King Bio's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 7
Official action indicated: 1
Last inspection ended: Jul 28, 2023
Warning letters: 1
Recalls since 2016: 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 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are 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 fully followed.
Voluntary Action Indicated (VAI)
Aug 12, 2021
Drugs · Drug Quality Assurance
7 cited references
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 211.110(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 211.184(c). Individual inventory record Records fail to include an individual inventory record of each component, reconciliation of the use of each component, drug product container and drug product closure with sufficient information to allow determination of any associated batch or lot of drug product.
21 CFR 211.84(d)(2). Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
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 211.111. 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. Written record of investigation incomplete Written records of investigations into do not include the conclusions and follow-up.
Voluntary Action Indicated (VAI)
Jul 20, 2018
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Sep 4, 2015
Drugs · Drug Quality Assurance
14 cited references
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 211.170(a). Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not retained.
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.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, 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 211.84(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 211.46(d). Penicillin air handling systems not kept separate Air-handling systems for the of penicillin are not completely separate from those for other drug products for human use.
21 CFR 211.166(a)(5). Testing of reconstituted drugs The written stability program does not include testing of drug products for reconstitution after they are reconstituted.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture, processing, and holding of a drug product lack the training required to perform their assigned functions.
21 CFR 211.42(c)(4). In-Process Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.
21 CFR 211.42(d). Penicillin processing area not kept separate The operations relating to the manufacture, processing, and packing of penicillin are not performed in facilities separate from those used for other drug products for human use.
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 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
21 CFR 211.176. Failing to test for penicillin cross-contamination Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.
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 compliance with established standards.
Voluntary Action Indicated (VAI)
Oct 15, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Oct 15, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Aug 10, 2011
Drugs · Drug Quality Assurance
6 cited references
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 testing and procedures.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
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 211.192. Quality control unit review of records Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the processing of a drug product lack the education and training required to perform their assigned functions.
21 CFR 211.84(e). Rejecting When Specifications Not Met Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Asheville, North Carolina, United States. Part of