FDA Intel

Bioreliance Ltd.

Form 483 issued September 27, 2019 · Glasgow, United Kingdom

Inspection
Sep 23 – Sep 27, 2019
Observations
3
Pages
2
FEI number
3005343934

In short: On September 27, 2019, FDA issued a Form 483 with 3 observations to Bioreliance Ltd. in Glasgow, Lanarkshire (FEI 3005343934) after an inspection that ran Sep 23 – Sep 27, 2019. Most observations concern facilities & equipment and production.

At a glance

Facilities & equipment and production account for 2 of 3 observations.

Facilities & equipment1
Production1
Quality system1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.67

    Written procedures for sanitation are not followed for the cleaning and maintenance of equipment used in…

  2. 02
    21 CFR 211.113

    Aseptic simulations used by the firm for…

  3. 03
    21 CFR 211.22

    Changes or repairs to equipment during on-demand maintenance and not always reviewed…

The full 483

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

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This inspection in context

The firm

Bioreliance Ltd. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.67

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Bioreliance Ltd.?

FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.

When was Bioreliance Ltd. inspected by FDA?

The inspection ran Sep 23 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.

How do I get the full Form 483 for Bioreliance Ltd.?

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