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FDA establishment 3002250546, Bowdoin, Maine, United States. Part of FHC, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 5
Official action indicated: 0
Last inspection ended: Jul 10, 2025
Warning letters: 0
Recalls since 2016: 3
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 820.40(b). Document changes, review and approval, communication Changes to documents were not communicated to appropriate personnel in a timely manner.
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 established.
21 CFR 820.30(h). Incorrect translation to production specifications The device design was not correctly translated into production specifications.
21 CFR 820.30(e). Design review - documentation The design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
Voluntary Action Indicated (VAI)
Oct 29, 2015
Devices · Compliance: Devices
5 cited references
21 CFR 820.75(a). Documentation Process validation activities have not been adequately documented .
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 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.80(c). Documentation In-process inspections, tests, or other verification activities and approvals were not documented.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record .
21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
21 CFR 820.22. Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited.
21 CFR 820.150. Lack of or inadequate procedures for storage. Procedures for the control of storage areas and stock rooms have not been adequately established.
21 CFR 820.70(a). Production processes Production processes were not controlled to ensure that a device conforms to its specifications.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
21 CFR 820.75(a). Documentation Process validation results have not been adequately approved.
21 CFR 820.30(g). Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.
21 CFR 820.70(g). Equipment Installation, Placement, Specified Requirements The equipment used in the manufacturing process does not meet specified requirements.
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 820.100(a). Lack of or inadequate procedures The procedures for implementing corrective and preventive actions were not implemented.
21 CFR 820.100(a)(2). Investigation procedures The corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system were not complete.
Voluntary Action Indicated (VAI)
Recalls
3 drug, device and biologic recalls since 2016, newest first; 1 Class I
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
Bowdoin, Maine, United States. Part of