Partner Therapeutics, Inc.
Form 483 issued July 22, 2022 · Lynnwood, Washington
- Observations
- 3
- Pages
- 4
- FEI number
- 3007934434
In short: On July 22, 2022, FDA issued a Form 483 with 3 observations to Partner Therapeutics, Inc. in Lynnwood, Washington (FEI 3007934434). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.22 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility to approve or rejec identity, strength, quality, and purity of…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Documenis relating to GMP operations…
This inspection in context
Questions about this 483
What did FDA find at Partner Therapeutics, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Partner Therapeutics, Inc. inspected by FDA?
This Form 483 is dated July 22, 2022.
How do I get the full Form 483 for Partner Therapeutics, 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.