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FDA establishment 1114298, Walkersville, Maryland, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 11
Official action indicated: 1
Last inspection ended: Mar 24, 2026
Warning letters: 0
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 820.90(b)(1). Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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.
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 820.75(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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action 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 have not been adequately established.
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 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated, inspected and maintained have not been adequately established.
Voluntary Action Indicated (VAI)
Feb 6, 2017
Devices · Compliance: Devices
10 cited references
21 CFR 820.25(a). Personnel Personnel do not have the necessary training to perform their jobs.
21 CFR 820.140. Lack of or inadequate procedures for handling Procedures for product handling have not been adequately established.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
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 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
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 established.
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 established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 807.22(b)(3). Listing not updated Existing device information changed, but the listing was not updated during June and December (or earlier) as required.
Official Action Indicated (OAI)
Jun 9, 2016
Biologics · Blood and Blood Products
None posted
Voluntary Action Indicated (VAI)
Aug 13, 2013
Biologics · Blood and Blood Products
None posted
Voluntary Action Indicated (VAI)
Dec 2, 2011
Biologics · Blood and Blood Products
8 cited references
21 CFR 600.14(a)(1). Who must report - manufacturer Failure to submit a biological deviation report.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures were not documented.
21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures were not implemented for monitoring and control of process parameters for validated processes.
21 CFR 820.150(a). Storage procedures to avoid release of unsuitable product Procedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or deteriorated product is distributed.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been defined for controlling environmental conditions.
21 CFR 820.100(a)(3). Identification of actions needed Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.
21 CFR 820.70(a). Production processes Production processes were not conducted and monitored to ensure that a device conforms to its specifications.
21 CFR 820.70(b). Production and process changes - failure to follow procedure Established procedures were not followed in making changes to processes.
Voluntary Action Indicated (VAI)
Aug 23, 2011
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Dec 17, 2009
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Oct 10, 2008
Biologics · Blood and Blood Products
10 cited references
21 CFR 820.25(b). Training Employees have not been adequately trained.
21 CFR 820.70(a). Process control procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications were not established and implemented.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures were not complete for the control of products that do not conform to specifications.
21 CFR 820.184. DHR content The device history record does not demonstrate the device is manufactured in accordance with the device master record.
21 CFR 600.14(a)(1). Who must report - manufacturer Failure to submit biological deviation reports.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process controls do not provide for documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been defined for controlling environmental conditions.
21 CFR 820.100(a)(3). Identification of actions needed Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.
21 CFR 820.90(b)(2). Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been fully documented in the device history record.
21 CFR 601.12(c). Moderate changes to an approved application Failure to submit a supplement prior to distributing product made using the change.
7382.850, Inspection of Medical Device Manufacturers
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
Walkersville, Maryland, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.