Polypeptide Laboratories Inc.
Form 483 issued August 30, 2019 · Torrance, California
- Inspection
- Aug 26 – Aug 30, 2019
- Investigator
- Santiago Gallardo Johnson
- Observations
- 1
- Pages
- 3
- FEI number
- 1000519239
In short: On August 30, 2019, FDA issued a Form 483 with 1 observation to Polypeptide Laboratories Inc. in Torrance, California (FEI 1000519239) after an inspection that ran Aug 26 – Aug 30, 2019. The investigator was Santiago Gallardo Johnson. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to follow established…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) 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 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Polypeptide Laboratories Inc.?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Aug 26 – Aug 30, 2019. Each investigator has a profile showing what they cite most.
When was Polypeptide Laboratories Inc. inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2019, and the Form 483 is dated August 30, 2019.
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.