Join Parachute, LLC
Form 483 issued February 27, 2025 · Bay City, Texas
- Inspection
- Feb 25 – Feb 27, 2025
- Investigators
- Barbara Peoples· Racquel N. East
- Observations
- 4
- Pages
- 3
- FEI number
- 3022728365
In short: On February 27, 2025, FDA issued a Form 483 with 4 observations to Join Parachute, LLC in Bay City, Texas (FEI 3022728365) after an inspection that ran Feb 25 – Feb 27, 2025. The investigators were Barbara Peoples and Racquel N. East. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.40 (facilities).
At a glance
3 of 4 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.40 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 606.40
Facilities must provide adequate space to perform manufacturing operations, including the performance of health history evaluations…
- 0221 CFR 606.40
Facilities must provide adequate lighting and…
- 03
The firm logged one deviation (NCR-24-8 1 14-8027) because in-house units collected from an reactive and…
- 0421 CFR 630.15
On donor DDR check was deemed unacceptable (DDR, - exact match), However, the donor was not…
This inspection in context
Barbara Peoples
1 document · 2025
Cites 606.40 (facilities) more than any other section. Most of their documents are for sites in Texas.
The firmJoin Parachute, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Join Parachute, LLC?
FDA listed 4 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.40 (facilities). The opening words of each observation are shown on this page.
Who inspected Join Parachute, LLC?
Barbara Peoples and Racquel N. East are named on this Form 483, for the inspection of Feb 25 – Feb 27, 2025. Each investigator has a profile showing what they cite most.
When was Join Parachute, LLC inspected by FDA?
The inspection ran Feb 25 – Feb 27, 2025, and the Form 483 is dated February 27, 2025.
How do I get the full Form 483 for Join Parachute, 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.