Bioreliance Ltd.
Form 483 issued March 15, 2019 · Glasgow, United Kingdom
- Inspection
- Mar 7 – Mar 15, 2019
- Investigator
- Cynthia Jim
- Observations
- 8
- Pages
- 6
- FEI number
- 3005343934
In short: On March 15, 2019, FDA issued a Form 483 with 8 observations to Bioreliance Ltd. in Glasgow, Lanarkshire (FEI 3005343934) after an inspection that ran Mar 7 – Mar 15, 2019. The investigator was Cynthia Jim. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.160 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic techniques used during testing of ce) samples in the Virology Laboratory are deficient regarding the…
- 02
Corrective and preventive actions are not alway's implemented…
- 03
Written procedures for sanitation are not followed for the cleaning and maintenance of equipment used in…
- 04
Written procedures for sanitation are not followed for the cleaning and maintenance of equipment used in…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmBioreliance Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioreliance Ltd.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Bioreliance Ltd.?
Cynthia Jim is named on this Form 483, for the inspection of Mar 7 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Bioreliance Ltd. inspected by FDA?
The inspection ran Mar 7 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Bioreliance Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.