Molecular Biologicals, LLC
Form 483 issued September 26, 2019 · Pasadena, Texas
- Inspection
- Sep 10 – Sep 26, 2019
- Investigator
- Ellen J. Tave
- Observations
- 2
- Pages
- 5
- FEI number
- 3013662224
In short: On September 26, 2019, FDA issued a Form 483 with 2 observations to Molecular Biologicals, LLC in Pasadena, Texas (FEI 3013662224) after an inspection that ran Sep 10 – Sep 26, 2019. The investigator was Ellen J. Tave. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
This inspection in context
Ellen J. Tave
8 documents · 2015–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmMolecular Biologicals, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Molecular Biologicals, LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Molecular Biologicals, LLC?
Ellen J. Tave is named on this Form 483, for the inspection of Sep 10 – Sep 26, 2019. Each investigator has a profile showing what they cite most.
When was Molecular Biologicals, LLC inspected by FDA?
The inspection ran Sep 10 – Sep 26, 2019, and the Form 483 is dated September 26, 2019.
How do I get the full Form 483 for Molecular Biologicals, 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.