Allay Pharmaceuticals, LLC
Form 483 issued November 15, 2021 · Miami, Florida
- Inspection
- Oct 25 – Nov 15, 2021
- Investigators
- Clinton J. Lott· Joanne E. King
- Observations
- 2
- Pages
- 4
- FEI number
- 3007007565
In short: On November 15, 2021, FDA issued a Form 483 with 2 observations to Allay Pharmaceuticals, LLC in Miami, Florida (FEI 3007007565) after an inspection that ran Oct 25 – Nov 15, 2021. The investigators were Clinton J. Lott and Joanne E. King. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.186 (master production and control records).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 820 (1×) · 211.186(b)(9) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Master production and control records lack complete manufacturing and control instructions and…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAllay Pharmaceuticals, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.186(b)(9)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allay Pharmaceuticals, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.186 (master production and control records). The opening words of each observation are shown on this page.
Who inspected Allay Pharmaceuticals, LLC?
Clinton J. Lott and Joanne E. King are named on this Form 483, for the inspection of Oct 25 – Nov 15, 2021. Each investigator has a profile showing what they cite most.
When was Allay Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 25 – Nov 15, 2021, and the Form 483 is dated November 15, 2021.
How do I get the full Form 483 for Allay Pharmaceuticals, 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.