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FDA establishment 3007490529, Port Elizabeth, South Africa. Part of Aspen Pharmacare Holdings Limited's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 2
Last inspection ended: Jul 14, 2026
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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 and test procedures designed to assure that components, drug product containers, closures, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
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 211.68(a). Calibration/Inspection/Checking not done Routine checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
Official Action Indicated (OAI)
Sep 17, 2024
Drugs · Drug Quality Assurance
12 cited references
21 CFR 211.28(a). Clothing appropriate for duties performed Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.
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 211.111. 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 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
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 to facilitate operations for its intended use.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
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 211.42(c)(10)(v). Cleaning System Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
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 products conform to appropriate standards of identity, strength, quality and purity.
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 and followed.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Official Action Indicated (OAI)
Dec 4, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Apr 19, 2016
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.28(a). Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.
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 products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.56(b). Written sanitation procedures lacking There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation.
Voluntary Action Indicated (VAI)
May 23, 2014
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
May 17, 2012
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
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
Port Elizabeth, South Africa. Part of