Polypeptide Laboratories Inc.
Form 483 issued May 10, 2024 · Torrance, California
- Inspection
- May 7 – May 10, 2024
- Investigators
- Andrew Le· Anney Lin· Michael Araneta
- Observations
- 1
- Pages
- 3
- FEI number
- 1000519239
In short: On May 10, 2024, FDA issued a Form 483 with 1 observation to Polypeptide Laboratories Inc. in Torrance, California (FEI 1000519239) after an inspection that ran May 7 – May 10, 2024. The investigators were Andrew Le, Anney Lin, Michael Araneta and Walden H. Lee. 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
Procedures used in the cleaning validation having sensitivity to detect residues or contaminants should be used…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmPolypeptide Laboratories Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Inc.?
FDA listed 1 observation 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 Inc.?
Andrew Le, Anney Lin, Michael Araneta and Walden H. Lee are named on this Form 483, for the inspection of May 7 – May 10, 2024. Each investigator has a profile showing what they cite most.
When was Polypeptide Laboratories Inc. inspected by FDA?
The inspection ran May 7 – May 10, 2024, and the Form 483 is dated May 10, 2024.
How do I get the full Form 483 for Polypeptide Laboratories Inc.?
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.