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FDA establishment 2510831, Newtown Square, Pennsylvania, United States. Part of Boiron's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 4
Official action indicated: 0
Last inspection ended: Jun 26, 2026
Warning letters: 0
Recalls since 2016: 1
Import refusals 2014 to 2023: 3, first Sep 21, 2018
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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.
Voluntary Action Indicated (VAI)
Oct 25, 2021
Drugs · Drug Quality Assurance
5 cited references
21 CFR 211.166(c)(1). Homeopathic drugs, assessment of stability There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Voluntary Action Indicated (VAI)
Feb 14, 2017
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Mar 18, 2011
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 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
Newtown Square, Pennsylvania, United States. Part of