Bio Products Laboratory Ltd
Form 483 issued August 30, 2022 · Elstree, United Kingdom
- Inspection
- Aug 22 – Aug 30, 2022
- Investigators
- Eileen A. Liu· Priscilla M. Pastrana
- Observations
- 7
- Pages
- 6
- FEI number
- 1000184635
In short: On August 30, 2022, FDA issued a Form 483 with 7 observations to Bio Products Laboratory Ltd in Elstree, United Kingdom (FEI 1000184635) after an inspection that ran Aug 22 – Aug 30, 2022. The investigators were Eileen A. Liu and Priscilla M. Pastrana. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigation of a failure of a batch to meet any of its specifications did not extend…
- 02
Biological product deviation reports (BPDRs) were not reported within…
- 03
Procedure designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmBio Products Laboratory Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bio Products Laboratory Ltd?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Bio Products Laboratory Ltd?
Eileen A. Liu and Priscilla M. Pastrana are named on this Form 483, for the inspection of Aug 22 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was Bio Products Laboratory Ltd inspected by FDA?
The inspection ran Aug 22 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
How do I get the full Form 483 for Bio Products Laboratory 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.