Reliable Biopharmaceutical, LLC
Form 483 issued February 21, 2020 · St. Louis, Missouri
- Inspection
- Feb 11 – Feb 21, 2020
- Investigators
- Jill Tillman· Michele Perry Williams
- Observations
- 6
- Pages
- 5
- FEI number
- 1927156
In short: On February 21, 2020, FDA issued a Form 483 with 6 observations to Reliable Biopharmaceutical, LLC in St. Louis, Missouri (FEI 1927156) after an inspection that ran Feb 11 – Feb 21, 2020. The investigators were Jill Tillman and Michele Perry Williams. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and/or the failure of a batch or any of…
- 02
The responsibility for production activities should be described in writing and should include, but not necessarily…
- 03
The training and qualification of production personnel should have written and approved procedures and documentation resulting…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Jill Tillman
7 documents · 2020–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Missouri.
The firmReliable Biopharmaceutical, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Reliable Biopharmaceutical, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Reliable Biopharmaceutical, LLC?
Jill Tillman and Michele Perry Williams are named on this Form 483, for the inspection of Feb 11 – Feb 21, 2020. Each investigator has a profile showing what they cite most.
When was Reliable Biopharmaceutical, LLC inspected by FDA?
The inspection ran Feb 11 – Feb 21, 2020, and the Form 483 is dated February 21, 2020.
How do I get the full Form 483 for Reliable Biopharmaceutical, LLC?
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.