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FDA establishment 3001022138, Madrid, Spain. Part of Optilasa, S.L.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 1
Last inspection ended: Oct 27, 2022
Warning letters: 0
Import refusals 2014 to 2023: 3, first Mar 26, 2015
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 820.198(a). Complaints Complaint files are not adequately maintained.
21 CFR 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers were not evaluated based on their ability to meet specified requirements.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements were not implemented.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for identifying training needs were not implemented.
21 CFR 820.30(j). Design history file The design history file was not established or maintained.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures were not established for the identification, documentation, validation or verification, review, and approval of design changes before their implementation.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers was not documented.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures were not followed for the control of products that do not conform to specifications.
21 CFR 820.100(b). Procedures The procedures addressing documentation of corrective and preventive action activities were not implemented.
21 CFR 820.20(d). Quality plan A quality plan was not implemented.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures have not been completed and implemented to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality Systems regulation.
21 CFR 820.72(b)(2). Calibration documentation There is no documentation of the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date for measurement equipment .
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits were not conducted to verify that the quality system is effective in fulfilling your quality system objectives.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review are not implemented.
21 CFR 820.70(a)(5). Criteria for workmanship Criteria for workmanship have not been expressed in documented standards or by means of identified and approved representative samples.
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
Madrid, Spain. Part of