Bioreliance Ltd.
Form 483 issued March 23, 2016 · Glasgow, United Kingdom
- Inspection
- Mar 14 – Mar 23, 2016
- Investigator
- Cynthia Jim
- Observations
- 17
- Pages
- 7
- FEI number
- 3005343934
In short: On March 23, 2016, FDA issued a Form 483 with 17 observations to Bioreliance Ltd. in Glasgow, Lanarkshire (FEI 3005343934) after an inspection that ran Mar 14 – Mar 23, 2016. The investigator was Cynthia Jim. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.67 (3×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all equipment are re-qualified, calibrated, and maintained at appropriate intervals…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Buildings do not have adequate space for the orderly placement of product, retain samples, stability samples…
- 04
Corrective actions are not always implemented on a timely basis…
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioreliance Ltd.?
FDA listed 17 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). 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 14 – Mar 23, 2016. Each investigator has a profile showing what they cite most.
When was Bioreliance Ltd. inspected by FDA?
The inspection ran Mar 14 – Mar 23, 2016, and the Form 483 is dated March 23, 2016.
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.