FDA Intel

Boiron Inc.

Form 483 issued October 25, 2021 · Newtown Square, Pennsylvania

Inspection
Oct 4 – Oct 25, 2021
Investigators
Anastasia M. Shields· Brandy N. Lepage
Observations
5
Pages
7
FEI number
2510831

In short: On October 25, 2021, FDA issued a Form 483 with 5 observations to Boiron Inc. in Newtown Square, Pennsylvania (FEI 2510831) after an inspection that ran Oct 4 – Oct 25, 2021. The investigators were Anastasia M. Shields and Brandy N. Lepage. Most observations concern laboratory controls and materials.

At a glance

3 of 5 observations on this 483 concern laboratory controls.

Laboratory controls3
Materials1
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.84(d)(2)

    Establishment of the reliability of the component supplier's report of analyses is deficient in that the…

  2. 02
    21 CFR 211.166(c)(1)

    There is no written assessment of stability of homeopathic drug products based at least on testing…

  3. 03
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit…

  4. 04
    21 CFR 211.165(a)

    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Anastasia M. Shields

45 documents · 2016–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.

The firm

Boiron Inc. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.84(d)(2)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Boiron Inc.?

FDA listed 5 observations on this Form 483, mostly about laboratory controls, materials and quality system. The opening words of each observation are shown on this page.

Who inspected Boiron Inc.?

Anastasia M. Shields and Brandy N. Lepage are named on this Form 483, for the inspection of Oct 4 – Oct 25, 2021. Each investigator has a profile showing what they cite most.

When was Boiron Inc. inspected by FDA?

The inspection ran Oct 4 – Oct 25, 2021, and the Form 483 is dated October 25, 2021.

How do I get the full Form 483 for Boiron Inc.?

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