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.
21 CFR 211.134(b). Representative samples after completion Samples of representative units were not collected and visually examined for correct labeling at the completion of finishing operations.
21 CFR 211.110(b). In-process conformity - examination, sample testing Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
21 CFR 211.184(b). Component Test Records The component records do not include the results of tests or examinations performed and the conclusions derived from tests or examinations performed.
21 CFR 211.165(d). Acceptance criteria for sampling & testing Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
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. 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 and warning letters
Mehsana, India. Every inspection FDA has posted for the site, with its outcome and cited regulations.