Allay Pharmaceuticals, LLC
Form 483 issued May 15, 2020 · Miami, Florida
- Inspection
- May 5 – May 15, 2020
- Investigator
- Jessica L. Pressley
- Observations
- 9
- Pages
- 14
- FEI number
- 3007007565
In short: On May 15, 2020, FDA issued a Form 483 with 9 observations to Allay Pharmaceuticals, LLC in Miami, Florida (FEI 3007007565) after an inspection that ran May 5 – May 15, 2020. The investigator was Jessica L. Pressley. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
EWPLOYEE(S) SIGNATURE Manufacturer There are no written procedures for production and process controls designed to assure…
- 04
The written stability testing…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allay Pharmaceuticals, LLC?
FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Allay Pharmaceuticals, LLC?
Jessica L. Pressley is named on this Form 483, for the inspection of May 5 – May 15, 2020. Each investigator has a profile showing what they cite most.
When was Allay Pharmaceuticals, LLC inspected by FDA?
The inspection ran May 5 – May 15, 2020, and the Form 483 is dated May 15, 2020.
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.