Polypeptide Laboratories San Diego, LLC
Form 483 issued May 15, 2025 · San Diego, California
- Inspection
- May 13 – May 15, 2025
- Investigator
- Deborah A. Greco
- Observations
- 6
- Pages
- 16
- FEI number
- 1000125456
In short: On May 15, 2025, FDA issued a Form 483 with 6 observations to Polypeptide Laboratories San Diego, LLC in San Diego, California (FEI 1000125456) after an inspection that ran May 13 – May 15, 2025. The investigator was Deborah A. Greco. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to follow written procedures for cleaning equipment and its release for use…
This inspection in context
Deborah A. Greco
2 documents · 2008–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmPolypeptide Laboratories San Diego, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Polypeptide Laboratories San Diego, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Polypeptide Laboratories San Diego, LLC?
Deborah A. Greco is named on this Form 483, for the inspection of May 13 – May 15, 2025. Each investigator has a profile showing what they cite most.
When was Polypeptide Laboratories San Diego, LLC inspected by FDA?
The inspection ran May 13 – May 15, 2025, and the Form 483 is dated May 15, 2025.
How do I get the full Form 483 for Polypeptide Laboratories San Diego, 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.