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FDA establishment 3002806497, Maidstone, United Kingdom. Part of Bedfont Scientific's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 4
Official action indicated: 2
Last inspection ended: Oct 31, 2019
Warning letters: 1
Import refusals since 2024: 2
Import refusals 2014 to 2023: 3, first Nov 26, 2019
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 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
Official Action Indicated (OAI)
Jun 14, 2016
Devices · Compliance: Devices
2 cited references
21 CFR 820.80(e). Documentation Acceptance activities were not adequately documented.
21 CFR 820.40(b). Document change records, maintained. Records of changes to documents were not maintained.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained, and implemented.
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 have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
21 CFR 820.70(i). Software validation for automated processes Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.250(b). Sampling plans Sampling plans are not written and based on valid statistical rationale.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
Official Action Indicated (OAI)
Aug 25, 2011
Devices · Compliance: Devices
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
Maidstone, United Kingdom. Part of