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FDA establishment 3010683157, Little Rock, Arkansas, United States. Part of SCA Pharmaceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 5
Official action indicated: 3
Last inspection ended: Oct 30, 2025
Warning letters: 1
Recalls since 2016: 9
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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
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 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Official Action Indicated (OAI)
May 17, 2023
Drugs · Drug Quality Assurance
4 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 cleaning and maintenance.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Voluntary Action Indicated (VAI)
Nov 7, 2019
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Sep 29, 2017
Drugs · Drug Quality Assurance
6 cited references
FDCA 503B(a)(10). Drug product label, outsourcer facility The labels of your outsourcing facility's drug products are deficient.
21 CFR 211.28(a). Clothing appropriate for duties performed Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
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 211.42(c)(10)(vi). Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Official Action Indicated (OAI)
Apr 2, 2014
Drugs · Drug Quality Assurance
7 cited references
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
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 prior to release.
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 211.56(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 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
21 CFR 211.28(a). Clothing appropriate for duties performed Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
21 CFR 211.42(c)(10)(vi). Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Official Action Indicated (OAI)
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
Little Rock, Arkansas, United States. Part of