Pharmadepot Labs, LLC
Form 483 issued June 18, 2024 · San Diego, California
- Inspection
- Jun 10 – Jun 18, 2024
- Investigator
- Claudia M. Perez-Kasmarski
- Observations
- 5
- Pages
- 4
- FEI number
- 3017534691
In short: On June 18, 2024, FDA issued a Form 483 with 5 observations to Pharmadepot Labs, LLC in San Diego, California (FEI 3017534691) after an inspection that ran Jun 10 – Jun 18, 2024. The investigator was Claudia M. Perez-Kasmarski. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Production and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 04
Batch production and control records are not prepared for each batch…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmPharmadepot Labs, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmadepot Labs, LLC?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Pharmadepot Labs, LLC?
Claudia M. Perez-Kasmarski is named on this Form 483, for the inspection of Jun 10 – Jun 18, 2024. Each investigator has a profile showing what they cite most.
When was Pharmadepot Labs, LLC inspected by FDA?
The inspection ran Jun 10 – Jun 18, 2024, and the Form 483 is dated June 18, 2024.
How do I get the full Form 483 for Pharmadepot Labs, 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.