Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3003338476, Sham Shui Po, Hong Kong SAR. Part of Wong Lap Kwong Medicine Company's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 211.188(a). Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
21 CFR 211.160(b)(3). Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.
21 CFR 211.84(d)(3). Container/Closure Written Test Procedure Drug product container and closure test procedures are deficient in that containers are not tested for conformance in accordance with appropriate written procedures.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
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 211.84(b). Representative Samples Criteria The amount of material taken from each container is not based upon appropriate criteria.
21 CFR 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing and packaging of the drug product.
21 CFR 211.122(c). Records fail to include Records kept for each different labeling and packaging material shipment fail to include the receipt, results of examination or testing and a statement of whether the shipment was accepted or rejected.
21 CFR 211.165(c). Sampling and testing plans not described Sampling and testing plans for drug products are not described in written procedures which include the method of sampling and number of units per batch to be tested.
21 CFR 211.67(b)(2). Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
21 CFR 211.105(b). Distinctive ID or code not recorded in batch record The batch records do not record the distinctive name of equipment to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
21 CFR 211.130(e). Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records.
21 CFR 211.84(c)(6). Identifying Containers Sampled Markings of containers from which samples have been taken are deficient in that they do not show that samples have been removed from them.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
21 CFR 211.110(c). In-process materials characteristics testing In-process materials are not tested for strength and quality and approved or rejected by the quality control unit after storage for long periods.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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 211.115(b). Reprocessing/quality control unit Reprocessing was performed without the review and approval of the quality control unit.
21 CFR 211.46(b). Equipment for Environmental Control Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
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 211.160(b)(2). Acceptance of in-process materials Determinations of conformance to appropriate written specifications for acceptance are not made for in-process materials.
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 211.192. 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.
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
