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 3020652309, Westborough, Massachusetts, United States. Part of Miach Orthopaedics's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 2
Official action indicated: 1
Last inspection ended: Jul 24, 2026
Warning letters: 1
Recalls since 2016: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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.
02018Inspections0
020192019Inspections0vs 2018+0
02020Inspections0vs 2019+0
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
02024Inspections0vs 2023+0
120252025Inspections1vs 2024+1
12026Inspections1vs 2025+0
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
ISO 13485:2016 Clause 7.5.7: Sterilization and sterile barrier system validation procedures not documented1
ISO 13485:2016 Clause 4.2.3: Medical device file does not contain specific requirements1
ISO 13485:2016 Clause 4.2.4: Document Control Procedure Inadequate1
ISO 13485:2016 Clause 7.3.9: Procedures to control design and development changes not documented1
ISO 13485:2016 Clause 7.5.7. Sterilization and sterile barrier system validation procedures not documented Procedures for the validation of processes for sterilization were not adequately documented.
ISO 13485:2016 Clause 4.2.3. Medical device file does not contain specific requirements The medical device file(s) does not include a general description and intended use/purpose of the medical device and labeling.
ISO 13485:2016 Clause 4.2.4. Document Control Procedure Inadequate The document control procedure does not adequately define controls needed to review, update as necessary, and re-approve documents.
ISO 13485:2016 Clause 7.3.9. Procedures to control design and development changes not documented Procedures to control design and development changes were not adequately documented.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers and consultants was not documented.
21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
21 CFR 820.30(c). Design input - Lack of or inadequate procedures Procedures for design input have not been adequately established.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records 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 820.198(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 - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.
21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
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
Westborough, Massachusetts, United States. Part of